Pharmaceutics
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Item ii Physicochemical Characterization of Native Cellulose and Microcrystalline Cellulose from Banana Pseudostem, Banana Peduncle, and Banana Leaf (Musa x paradisiaca L.) and Evaluation of Microcrystalline Cellulose as a Directly Compressible Excipient(Addis Ababa University, 2023-09) Wledesilasse,Amanuel; Belete,Anteneh(Dr.); Joseph,Nisha Mary(Dr.); Gabriel,Tesfaye(Dr.)Wood is the most common source of cellulose, but over exploitation and deforestation have led to a need for alternative sources. Banana (Musa spp.) is produced as a multi- purpose crop in terms of food security, income generation, job opportunities, and animal feeding in Ethiopia. However, the cultivation of bananas gives rise to a large number of byproducts such as pseudostem, leaves, inflorescence, rhizomes, pith, sap, and fibers. This study therefore aimed to isolate and characterize native cellulose and microcrystalline cellulose (MCC) from banana leaf (BL), Banana pseudostem (BS), and Banana peduncle (BP) and evaluate MCC as a directly compressible pharmaceutical excipient. Cellulose fibers were obtained using a chlorine-free extraction process that began with sodium hydroxide pretreatment. The fibers were then delignified with a mixture of formic acid, acetic acid, and hydrogen peroxide, and bleached with alkaline hydrogen peroxide. MCC was prepared by hydrolyzing the native cellulose fibers with hydrochloric acid (HCl). The isolated cellulose and MCC were then characterized using different analytical techniques: Fourier-transform infrared spectroscopy (FTIR), X-ray diffraction (XRD), Scanning electron microscopy (SEM), and Thermogravimetric analysis (TGA). The formulated tablets were evaluated for uniformity of weight, hardness, friability, disintegration time, and dissolution rate. The FTIR results tracked the gradual removal of non-cellulosic components from the extracted cellulose. SEM images showed that the cellulose samples had a micro-fibrillated structure, while the MCC samples had a rod-like shape with some irregular aggregated particles. All samples of cellulose and MCC showed thermal stability. XRD analysis showed that BL-MCC, BS-MCC, BP-MCC, and Avicel PH-101 had crystallinity indices of 77%, 84%, 83%, and 85%, respectively, and degree of polymerization (DP) values of 270, 265, 255, and 240, respectively. The yields of cellulose and MCC from BL, BS, and BP were 23.1 ± 1.41%, 37.33 ± 1.4%, and 45 ± 0.8%, respectively. The yields of MCC from BL, BS, and BP were 77.5 ± 0.4%, 85 ± 0.7%, and 87.3 ± 0.47%, respectively. Both without paracetamol and paracetamol-loaded tablets made with BS-MCC and BP-MCC had acceptable crushing, tensile strength, and friability. The disintegration times and drug release profiles of all paracetamol-loaded tablets made with BS-MCC, BP-MCC, and Avicel PH-101 were similar and within the acceptable range specified in the USP. This study proposes that BL, BS, and BP are locally available xvi sources of cellulose and MCC with potential as direct-compressible tablet excipients in pharmaceuticals, providing an alternative to local sources.Item Reverse Logistics Practice, Challenges, Opportunities and Employee’s Perception: The Case of Ethiopian Pharmaceuticals Supply Service(Addis Ababa University, 2023-11) Mebrate,Hirut; Teshome,Dawit(MSc, MA)In the pharmaceutical industry, reverse logistics specifically refers to a return of pharmaceuticals due to over-stock, distribution error, damage, quality problems including counterfeit products, expiry and clinical trial recoveries. A good reverse logistics system keeps the public's safety, saves costs, and gains a competitive advantage including increased reliability of the supplier. Despite its importance, in developing countries, attention given to RL activity is minimal compared to the forward logistics, and Ethiopia's practice isn’t an exception. This study aimed to explore the current reverse logistics practice of EPSS and document the challenges, opportunities and employee perceptions associated with its implementation. An institutional-based cross-sectional study design was used and data were collected using a self-administered questionnaire, key informants’ interview and data abstraction tool. The self-administered questionnaires were distributed to 158 professionals and were supplemented by in-depth key informant interviews with 11 directors working in the selected EPSS hubs. The collected quantitative data were analyzed using SPSS V-26 descriptive statistics and the qualitative findings were analyzed with generated six themes. The study revealed that reverse logistics practice exists in EPSS. However, the practice is in its premature stage as it lacks core components of planning, designing and standardization of the process, and setting a well-documented policy and procedure for RL. The main driving forces were increasing stock availability and customer satisfaction followed by the government policy of social responsibility. The key challenges arise from a lack of definite rules and regulations on handling returned products, the unpredictability of return dynamics and forecasting complexity coupled with a lack of appropriate technology. The leading opportunities were found to be the existence of responsible RL and incinerator management directorate, and high-temperature incinerator availability. Employees have a positive perception towards RL practice and believe that RL increases customer satisfaction and brings a competitive advantage. Based on the findings, it is recommended that EPSS to focus on the pre-planning activities of RL and follow its cost- effective implementation, strengthening communication with both upward and downward supply chain partners as well as improving the management commitment towards RL practice.Item Plant Glucosylceramides and Mosquito Repellent Essential Oils Loaded Nano Carriers for Topical Applications: Formulation, Optimization and In Vitro Release Studies(Addis Ababa University, 2023-09) Adem,Admassu Assen(PhD); Gebre-Mariam,Tsige(Prof.); Neubert,Reinhard H.H.(Prof.)Skin protects the body against the invasion of external pathogens, allergens, and chemical substances. It is considered that most of the skin barrier function resides in the epidermis, particularly in its outermost layer, stratum corneum (SC). The SC is composed of corneocytes embedded in a lipid-enriched intercellular matrix. Ceramides (CERs), free fatty acids (FFAs), and cholesterol are the major components of the lipid matrix in an approximately 1:1:1 molar ratio. The unique molecular organization and the equi-molar ratio are considered crucial in barrier function and semipermeable nature of the SC. Compositional and organizational changes in SC lipids such as CERs cause defective skin barrier function in relation with ageing and skin disorders partly due to altered enzymatic activity. However, the glucocerebrosidase enzyme responsible for the conversion of glucosylceramides (GlcCERs) to CERs is not affected by ageing. It has been shown that direct topical replacement of depleted native skin CERs has beneficial effects in improving skin barrier function and skin hydration. CERs are obtained from animal, plant and synthetic sources. Plants are more reliable sources of CERs, as animal and synthetic CERs have safety/ethical issues and affordability challenge, respectively. Though plants are preferred, most of the plant sphingolipids (SPLs) are available in a complex form with a polar head group attached to the CERs. It requires an economical and effective method of hydrolysis to produce CERs from dominant SPLs such as GlcCERs. Moreover, the poor solubility and permeability of CERs on top of normal SC barrier property make the delivery of topical CERs challenging using conventional formulations. While GlcCERs/CERs are intended to be delivered to the upper layer of the skin, the present study also considered formulating essential oils having mosquito repellent activity for topical application. The mosquito repellent potential of plant materials has been exploited for centuries using different means, including applying essential oils on the skin iv | P a g e and clothes to combat transmission of malaria. However, due to the volatile nature of essential oils, the protection against mosquitoes is short-lived. Therefore, the objectives of this PhD work were to explore potential GlcCER plant sources, investigate suitable chemical and enzymatic methods of hydrolysis of plant GlcCERs into CERs and develop an optimized nanoemulgel formulation for topical delivery of the plant GlcCERs as well as to formulate citronella oil (CO) (Cymbopogon nardus) and palmarosa oil (PO) (C. martini) in the form of nanoemulgel (NEG) to delay the volatility of the essential oils upon application. GlcCERs were isolated from lupin bean (Lupinus albus), mung bean (Vigna radiate) and naked barley (Hordium vulgare). The GlcCERs were identified using ultra high- performance liquid chromatography hyphenated with atmospheric pressure chemical ionization-high resolution tandem mass spectrometer (UHPLC/APCI-HRMS/MS) and quantified with validated automated multiple development-high performance thin layer chromatography (AMD-HPTLC) method. The GlcCERs were hydrolyzed into CERs with mild acid hydrolysis (0.1N HCl) following treatment with an oxidizing agent, NaIO4, and reducing agent, NaBH4. After securing ethical clearance, excised human skin was employed to investigate the enzymatic hydrolysis of plant GlcCERs. Homogenized epidermis in citrate phosphate buffer was incubated with lupin GlcCERs. The total lipid was extracted with MeOH/CHCl3/H2O solvent mixture and the unhydrolyzed lupin GlcCERs in the extract was quantified using a UHPLC-QqQ-MS/MS method in MRM (multiple ion reaction monitoring) mode (m/z 714.5 →696.54→ 262.25). Formulations of GlcCERs were developed for topical delivery. The Nanoemulsion (NE) components were screened and pseudo-ternary phase diagrams were constructed at different hydrophilic- lipophilic balance (HLB) values of surfactant-co-surfactant mixture (Smix). Extreme vertices mixture design was developed to investigate the impact of percentage compositions of the independent variables; oil mixture (2-3%), Smix (15-18%) and aqueous component (79-83%) on the globule size of the NEs. NEG was prepared from optimized 0.25% lupin GlcCER NE and Carbopol 980 gel. The membrane penetration depths of GlcCERs loaded optimized NEs and NEGs were measured. v | P a g e NE for both essential oils were also prepared using ultrasonication technique following suitable HLB selection of Smix and phase diagram development. NEGs were formulated by mixing NEs and Carbopol 934 gel. Physicochemical characterizations, including in vitro release and permeation studies were carried out. The Gas chromatography hyphenated mass spectrometry method for identification and quantification of essential oils was validated. GlcCERs with 4,8-sphingadienine, 8-sphingenine and 4-hydroxy-8-sphingenine sphingoid bases linked with C14 to C26 α-hydroxylated FAs were identified from all the three plants. Single GlcCER (m/z 714.5520) was dominant in lupin and mung beans, while five major GlcCERs species (m/z 714.5520, m/z 742.5829, m/z 770.6144, m/z 842.6719 and m/z 844.56875) were obtained from naked barley. The GlcCERs contents of the three plants were comparable. However, lupin bean contained predominantly a single GlcCER (m/z 714.5520). CER species bearing 4,8-sphingadienine and 8-sphingenine sphingoid bases attached to C14 to 24 FAs were found after mild acid hydrolysis. CER species with m/z 552.4992 was the main component in the beans while CER with m/z 608.5613 was dominant in the naked barley. However, CERs with 4-hydroxy-8-sphingenine sphingoid base were not detected with UHPLC-HRMS/MS. Following skin enzyme hydrolysis investigation, the characteristic signals of GlcCER fragments (m/z 696.54, 552.49 and 534.48) due to in-source fragmentation were detected in the MS spectra of the skin extract. The MS2 fragmentation of the dominant fragment (m/z 696.54) ion provided the target product ion (m/z 262.25) which was integrated to quantify GlcCER. The LC-MS method was selective, precise and accurate. It was also free from matrix and carryover effects. The unhydrolyzed lupin GlcCER amount decreased with time suggesting hydrolysis of GlcCERs by the skin enzymes. An optimized NE formulation was prepared. The HLB values of 13.5 and 12 provided broader NE regions for Miglyol and isopropyl myristate, respectively. The analysis of variance of the quadratic model showed suitability of the model with R2 of 99.80% and non-significant lack of fit (F value= 17.06). The optimized percentage compositions of oil phase, Smix and aqueous phase were 2.15%, 16.39% and 81.46%, respectively, with predicted globule size of 23.96 nm. Accordingly, the optimized NE globule size, polydispersity index and zeta potential were 23.93 ± 0.25 nm, 0.069 ± 0.017 and 23.95± 1.20 mV, respectively. The oil globules were spherical and distributed vi | P a g e uniformly without aggregation. The NE exhibited Newtonian flow with a viscosity of 6.75 mPa.s, while NEGs showed non-Newtonian flow with shear thinning property. The amount of lupin GlcCER released and penetrated into each model membrane layer at different time points was in the order of NEs > basic cream > NEGs. After 180 min, 51%, 84% and 96% of lupin GlcCER was released and penetrated into the model membrane layers from NEG, basic cream and NEs, respectively. The formulation developed for the topical application of essential oils employed CO and PO as the oil components. Tween 80, Transcutol P and distilled water with 40% glycerol were selected as surfactant, co-surfactant and aqueous components of the NE, respectively. HLB values of 11 and 12 were found to be appropriate for CO and PO NEs preparation, respectively. Clear CO and PO NEs with an average globule size of 131.34 nm and 120.77 nm, respectively, were obtained. The NEG preparations of both essential oils were kinetically stable, and the formulation components were chemically compatible with each other. In conclusion, considering affordability, GlcCER content and yield, lupin bean would be the preferred alternative commercial source of GlcCERs. The mild acid hydrolysis method is economical and effective, mainly for plant GlcCERs carrying dihydroxy sphingoid bases. Plant GlcCER hydrolysis in skin homogenate, being investigated for the first time, the findings pave the way for a new mode of skin barrier function enhancement modality. Taking into account the drawbacks of animal and synthetic CERs on top of enzymatic and chemical methods of plant GlcCER hydrolysis limitations, topical administration of plant GlcCER to enhance skin barrier function would be the preferred alternative. The NEG formulation developed for dermal delivery of lupin GlcCERs prolonged the release and slowed down the penetration of GlcCER into the multilayer membrane model which is crucial to limit its penetration into the epidermal skin layer. Therefore, NEGs could be considered as an option for the delivery of plant GlcCER into the upper part of the skin after further ex-vivo investigation, as the study is the first of its kind. Regarding formulations of the essential oils, NEGs prolonged the release of both CO and PO up to 24 h and significantly reduced the percentage permeation via cellulose acetate membrane as compared to NEs. Therefore, NEG could be an alternative formulation to prolong the mosquito repellent effect of essential oils.Item Formulation, optimization and in vitro characterization of microcapsules of Cymbopogan martini essential oil(Addis Ababa University, 2023-01) Haile,Christina; Belete,Anteneh(Dr.)Complex coacervation is one of the microencapsulation techniques by which encapsulated substances release profile improved. This study was conducted by using complex coacervation to formulate and optimize microcapsules of the Cymbopogan martini essential oil. The preliminary study was conducted to define the optimal polymeric ratio for the coating materials (gelatin B and sodium alginate) and the optimal pH for coacervate by taking dry coacervate yield and turbidity as response variable. In screening study eight factors, total polymeric concentration, Palmarosa oil concentration, surfactant concentration (Tween 80), reaction time, temperature, stirring speed, crosslinker concentration (Tannic acid) and crosslinking time were screened by Plackett–Burman design generated by Minitab software using encapsulation efficiency, microcapsules surface property, microcapsules size and distribution as response variables. The three significant factors from screening design, total polymeric concentration, Palmarosa oil concentration and Surfactant concentration were further optimized by taking encapsulation as response variable, which had significant relationship with factors in screening design. Finally, the optimized microcapsules oil release was fitted to zero and first order kinetics models. The optimal polymeric ratio and optimal pH were 0.3:1 and 3.5, respectively and in the optimization study quadratic mathematical model (p < 0.0001) was an excellent fit to analyze the relationship between factors and response variable (R2, R2adj and R2 pred were > 0.9). The optimal encapsulation efficiency was 96.7% and the zero-order kinetics model (where R2 = 0.9937) was defined the oil release from microcapsules.Item Multi-Criteria Inventory Classification of Pharmaceuticals for Inventory Management Optimization: The Case of Public Hospitals in Addis Ababa, Ethiopia.(Addis Ababa University, 2023-12) Mekonnen,Mesay; Tilahun,Zelalem(Ass. Prof.)Background: Inventory management is the heart of the pharmaceutical supply chain system. Effective and efficient management of medical stores requires close monitoring of important drugs, prevention of the pilferage and priority in purchase and distribution of drugs that would help to optimize use of resources and eventually help to improve patient care, by ensuring the availability of essential stocks and preventing stock-outs. Implementation of different types of products’ classification and categorization for inventory optimization is critical to minimize the inventory cost and maximize inventory efficiency. Objective: To describe multi-criteria inventory classification of pharmaceuticals for inventory management optimization in Addis Ababa public hospitals. Methods: Facility-based descriptive cross-sectional study design with mixed research approach was conducted to retrospectively review logistic data from the digital health commodity management information system (HCMIS) and manual records of 2012-2013 EFY. The quantitative data was analyzed using Microsoft excel spreadsheet and SPSS version 20, while the qualitative data was analyzed thematically. Result: The ABC – VED matrix analysis revealed that 264 (33.67%) of category (AV, AE, AD, BV, CV) items account for 84.65 % of total pharmaceutical expenditure (TPE), of which the highest amount (32.54%) & (31.17%) was AE & AD items 30 (3.83%) & 50 (6.38%) respectively. From FSN – XYZ matrix analysis Category Ⅰ consists (FX, FY, FZ, SX & NX) that hold 30.35% of items with 68.12% of total pharmaceutical expenditure (TPE) and 40.21% of items were category Ⅱ (SY, SZ & NY) holds 11.1% of TPE. The remaining 22.44% of items accounted 21.2% of TPE were grouped under category Ⅲ (NZ) in 2012. On the other hand Category Ⅰ holds 36.29% of items that accounted 90.64% of TPE, category Ⅱ and category Ⅲ holds 51.87% &11.83% of items that accounted 9.05% & 0.31% of TPE in 2013, respectively. viii Conclusion: ABC-VED matrix analysis of present study showed that category Ⅰ pharmaceuticals holds large amount (84.65%) of budget that needs greater attention for control which avoids wasting extra funds on the purchase of drugs that are not really necessary. Category I consumed 68.12% and 90.64% of total consumption in 2012 and 2013, respectively, according to the FSN-XYZ matrix study. According to this finding, NZ class products spent more budgets (21.2%) in 2012 than 2013 (0.3%). which are non-moving and have low closing values, which creates an issue with a lack of available space and a high rate of waste. In 2013, Category I consumed 90.64% of all pharmaceutical spending and required tight manager supervision. This study also examined the inventory management practices with in public hospitals, and the findings indicated that while ABC-VED analysis is used in these facilities, it is not updated yearly. FSN-XYZ analysis is not used in any of the hospitals. To reduce overstock and stock out, the hospitals used different inventory control techniques, such as minimum/maximum, routine physical inventory, bin cards, and stock cards.Item Vaccination Dropout, Socioeconomic Inequality and Spatial Distribution of Vaccination Dropout and Zero-Dose Children Aged12-35 Months in Remote and Underseved Settings of Ethiopia.(Addis Ababa University, 2024-04) Shiferie,Fisseha(Phd); Fenta,Teferi Gedif( MPH, PhD); Gebremedhin,Samson(MPH, PhD); Andargie,Gashaw(MPH, PhD)Vaccination is considered as one of the most successful and cost-effective public health measures, averting millions of deaths every year. Although vaccination coverage is increasing globally, many children in low- and middle-income countries drop out of the vaccination continuum. Globally, 25 million children were either underimmunized or zero-dose in 2021. Inequality in access to childhood vaccinations is also another major obstacle to the astounding progress in basic vaccination coverage. This study was conducted to estimate the prevalence of vaccination dropout, examine socioeconomic inequalities in vaccination dropout, decompose socioeconomic inequalities and map the spatial distribution of zero-dose and measles vaccination dropout children in underserved settings of Ethiopia. A generalized estimating equation was used to assess determinants of vaccination dropout and concentration curve and index were used to estimate wealth related inequality of vaccination dropout. A decomposition analysis approach was used to decompose socioeconomic inequalities into the contributions of individual factors to inequalities in vaccination dropout. Spatial autocorrelation was measured using the Global Moran's I statistic. Getis- Ord Gi* statistics was applied to calculate the spatial variability of zero-dose and measles vaccination dropout cases. Spatial interpolation technique was also applied to predict unknown values that fall between known values. A total of 3,646 mothers/caregivers of children participated in the study. The overall Penta-1 to Penta-3 dropout estimate was 44%. Developing regions and urban slums had the highest and the lowest vaccination dropout estimates (60.1% and 11.2%), respectively. Caregivers who were working outside their homes, who did not receive a service from a skilled birth attendant, who were less gender empowered and who were in the lowest wealth strata had increased odds of Penta-1 to Penta-3 dropout. Inequalities in vaccination dropout were significantly and disproportionately concentrated among the poor (CI = −0.179; p < 0.01). According to the decomposition analysis, wealth index, place of residence, skilled birth attendance, and availability of a health facility in the kebele contributed the most to socioeconomic inequalities in vaccination dropout. Overall, MCV-1 and MCV-2 coverages were 67% and vi 35%, respectively. On average, the measles vaccination dropout estimate was 48.3%. Refugees and urban slums had the highest and the lowest measles vaccination dropout estimates (56.4% and 37.7%), respectively. The hot spot analysis detected the highest burden of measles vaccination dropout in the Afar Region’s zones 1 and 5, the Amhara Region’s North Gondar Zone and the Somali Region’s Siti Zone. Western, eastern and northern parts of Somali and western and central parts of Afar regions had the highest load of zero- dose children. Vaccination dropout estimates were high among children residing in remote, hard-to-reach, and conflict-affected settings of Ethiopia. The overall MCV-1 and MCV-2 coverage estimates were low, measles vaccination dropout was high. The highest burdens of zero-dose and measles vaccination dropout cases were detected mainly in the northeastern parts of Ethiopia. Strengthening horizonal integration of immunization services with maternal & child health services and empowering women would help reduce vaccination dropout. Due to its recent introduction, the lack of awareness around MCV-2 needs to be addressed, especially in the northeastern part of Ethiopia.Item Patient and Provider Experiences on Differentiated Antiretroviral Therapy Service Delivery Models in Addis Ababa Health Fa cilities: A Mixed-Methods Study(Addis Ababa University, 2024-10) Mesele, Kidist; Eshetu, Eskinder (PhD); Tekle ,GirmaBackground: Following the World Health Organization's (WHO) recommendation of the Differentiated Service Delivery (DSD) models as a client-centered approach in 2016, Ethiopia has been implementing these models since 2017. However, there is paucity of information on the impact of the DSD model implementation in Ethiopia. Objective: To assess patient and provider experiences with the implementation of Antiretroviral therapy (ART) DSD models in selected health facilities of Addis Ababa, Ethiopia. Methods: A mixed-methods sequential explanatory study design was undertaken among People Living with HIV (PLWH) and healthcare professionals at 10 selected health facilities of Addis Ababa. For the quantitative study, convenient sampling was employed, while purposive sampling method was used for the qualitative study. Mann-Whitney U and Kruskal Wallis tests were performed to determine the difference in the patient satisfaction among subgroups of patients. Multivariable Tobit regression was performed to identify factors associated with patient satisfaction. Thematic analysis was used to interpret the qualitative data. Results: Four hundred fifteen PLWH were included in the final analysis. The majority (266, 64.1%) were female and 185 (44.6%) were enrolled in Appointment Spacing Model (ASM). The median score of patient satisfaction was 76.5. Viral load count of <1000 copies/ml, high adherence level and being on first line regimen were significantly positively associated with high patient satisfaction. There was no satisfaction difference among the DSD models. The qualitative analysis documented patients’ and professionals’ perspectives in the areas of service efficiency, perceived patient outcomes, and integration with other chronic patient care services. Conclusion and recommendation: The study found that patients expressed a high level of satisfaction with DSD models. Factors such as the type of regimen, patient adherence status, and viral load amount significantly influenced satisfaction. Perceived stigma with community DSD models, low awareness on DSD models, fear of detachment from the health facility, and supply chain inconsistency were the reported barriers with ART DSD models. Majority of the study participants believed that the integration of HIV care with other chronic condition was beneficial. Policy makers, federal ministry of health, and health care providers should consider addressing the barriers associated with DSD models.Item Carboxymethylation of Phoenix dactylifera L palm tree cellulose and its evaluation as pharmaceutical suspending agent(Addis Ababa University, 2024-06) Yesuf, Nurlgn; Belete,Anteneh(Prof.); Gabriel,Tesfaye(Dr.); Brhane,YonasPhoenix dactylifera L palm tree is a plant with great sustainability and renewability in nature and widely spread across much of Middle East, tropical Africa including Ethiopia. Its fiber biomass mainly comprises lignocellulose, and used as an alternative source of cellulose. The objective of this study was to extract and characterize cellulose from the leaves and leaf base of local Phoenix dactylifera L palm tree; modify the extracted cellulose to carboxymethyl cellulose (CMC) and evaluate the CMC as pharmaceutical suspending agent. Leaves and leaf base of Phoenix dactylifera L palm tree were individually subjected to extraction of cellulose, followed by the carboxymethylation process by utilizing monochloroacetic acid and sodium hydroxide. Characterization techniques including Fourier Transform Infrared Spectroscopy, Scanning electron microscopy, X-Ray Diffraction, and Thermogravimetric Analysis were employed to assure the successful extraction of cellulose as well as the modification of cellulose to CMC. The percent of cellulose yields on a dry weight basis was found to be 36.7 + 0.97 % for cellulose extracted from palm tree (Phoenix dactylifera L) leaves and 41.3 + 1.08 % from leaf base. The maximum degrees of substitutions of CMC were 0.889 for (Carboxymethyl cellulose derived from Phoenix dactylifera L tree leave) (L-CMC) and 0.667 (for Carboxymethyl cellulose derived from Phoenix dactylifera L Leaf base cellulose (LB-CMC)) based on dry weight conditions. The yield of CMC ranged from 0.889 + 0.003 g/g (for L‐CMC) to 0.179 + 0.001 (for LB‐CMC). L-CMC and LB-CMC were evaluated as suspending agents in metronidazole benzoate suspensions. The suspensions were prepared using 0.5%, 1%, 1.5%, and 2% w/v of L-CMC, and LB-CMC, and compared with suspensions prepared from commercial carboxyl methyl cellulose (C-CMC) in similar concentrations. The resulting suspensions were evaluated for their visual appearance, pH, sedimentation volume (%), rheology, redispersibility, and in vitro drug release profile, and also stability studies at accelerated condition were performed for 3 months. The flow rate and redispersibility of the metronidazole benzoate suspension prepared with L-CMC were significantly lower than those with C-CMC and higher than those prepared with LB-CMC at 1 % w/v suspending agent concentrations(p>0.05). The sedimentation volume of the formulations was in the order of C-CMC > L-CMC> LB-CMC (p>0.05). Additionally, the dissolution rate profiles of all the prepared metronidazole benzoate suspensions remained similar to the Negazole, Camezola, and Metrogly with f2 > 50. The results indicate successful carboxymethylation of palm tree cellulose, and yielding CMCs with desired physicochemical properties as pharmaceutical suspending agent.Item The quality of physical distribution service at the Ethiopian pharmaceutical supply service using a mixed method approach: a case of Dire Dawa Branch(Addis Ababa University, 2024-05) Alemayehu,Saron; Gedif,Teferi(Prof.); Kreie,Andre(Dr.)Background - Customer satisfaction is one of an agile supply chain's most commonly utilized key performance metrics. In low- and middle-income nations, inefficient distribution practices directly drive-up costs, resulting in medicine stock-outs. Studying distribution service quality in Ethiopia’s health sector is vital for improving health-care services and implementing national health-care quality strategies. Method - The study was conducted at Ethiopian pharmaceutical supply service (EPSS) Dire Dawa Branch and 56 health facilities in East Harerghe, West Hararghe, Harari region, Somali, and Dire Dawa from Dec 1, 2023 - Jan 30, 2024. An institution-based cross-sectional study with a concurrent mixed method approach was conducted to assess health facilities' satisfaction with the physical distribution service of EPSS using the physical distribution service quality model (PDSQ), which compares customers' expectations with the perception to generate a gap score and measure service quality. The study also identified service challenges in the EPSS Dire Dawa branch using key informant interviews. A stratified random sampling proportionate to size technique was applied to select hospitals and health centers from the four regions under the catchment of EPSS Dire Dawa Branch, and purposive sampling was used to select key informants. Result- The study revealed that expectation measurement ranges from 4.34 - 4.79 for program commodities and 4.38 - 4.82 for RDF commodities, indicating high expectations in both cases. The mean perception value for all four dimensions (Availability, Timeliness, product quality and responsiveness) ranges from 2.49 - 3.85. The gap score for all four dimensions is negative in both health commodity types, ranging from -0.69 to -2.34, which indicates the physical distribution service quality is perceived as low. The mean Gap score for availability was -2.03 and -2.11 in both program and RDF commodities respectively. Regarding the indirect measure of customer satisfaction, the gap score for all four dimensions is negative. It should be noted that the physical distribution service public health facilities receive from EPSS is less satisfactory. The direct measurement of customer satisfaction shows that health facilities have a good level of satisfaction with the condition of health commodities delivered, average satisfaction with timeliness of delivery, and responsiveness. The lowest satisfaction level was attained with the availability of products. The study also indicated that there was a significant difference in v customer satisfaction between RDF and the program distribution system regarding the availability of health commodities (X2 =13.08, df=4) and (P value = 0.004). Regarding challenges of the physical distribution service transportation challenges with the RDF distribution system, poor availability of pharmaceuticals, prolonged order cycle time, lack of supervision, and budget shortage are the main challenges faced by health facilities. Key informants from EPSS Dire Dawa branch indicated poor data quality, delay in replenishment from central EPSS, and lack of vehicle as challenges of the distribution service it provides. Conclusion- Logistics customer service quality measurement is essential to meet customer requirements.The study found that the physical distribution service of EPSS, Dire Dawa branch, sub-optimal regarding all the physical distribution quality model dimensions, availability of health commodities, timeliness, product quality, and responsiveness.Item Preparation and Characterization of Cellulose from Bamboo Wood and Eucalyptus Sawdust, and Evaluation of the Derivative Sodium Carboxymethyl Celluloses as Suspending Agents(Addis Ababa University, 2024-09) Gebreegziabher,Sine; Gebre-Mariam,Tsige(Prof.); Belete,Anteneh(Prof.)Cellulose has gained a great deal of interest from researchers due to its high demand in paper, food, cosmetics, textile and pharmaceutical industries. Woody plants and cotton are the major sources of cellulose and its derivatives such as sodium carboxymethyl cellulose, microcrystalline cellulose, cellulose acetate and hydroxypropyl cellulose. However, overutilization of these sources has raised huge economic and environmental concerns forcing researchers and stakeholders to look for other potential substitutes. In Ethiopia, bamboo wood (BW) and eucalyptus sawdust (ES) are abundant and can be exploited as potential raw materials for cellulose extraction. The aim of this study was therefore to extract and characterize native cellulose from BW and ES, and evaluate the derivatives BW-SCMC and ES-SCMC as suspending agents in suspension formulations. In this study, cellulose fibers were extracted from the aforementioned sources by steam explosion method. SCMC was obtained from the extracted cellulose fibers, following alkalinization and etherification steps using sodium hydroxide and monochloroacetic acid (MCA) in isopropyl alcohol. Central composite design (CCD) with three coded values was employed. The amount of MCA, duration of etherification and temperature of etherification were selected as independent variables; and the degree of substitution (DS) was taken as the response variable during optimization. By comparing several statistical parameters, two quadratic models were selected as best fit for DS of BW-SCMC and ES-SCMC. The adequacy of the models as per ANOVA revealed that both models have significant values indicating the terms in the models have significant effect (P < 0.0001) on the response. The cellulose yields on dry weight basis were found to be 48.06% ± 1.02 (BWC) and 44.21% ± 1.14 (ESC). The isolated BWC and ESC have DP of 524.64±0.89 and 701.51±1.16, and molecular weight of 84,990.87 g/mol and 113,644.62 g/mol, respectively. The crystallinity index of BWC and ESC was found to be 74.3% and 79.2%, respectively. Furthermore, Fourier transform infrared (FTIR) spectra’s indicated removal of non-cellulosic constituents. An optimum DS of 1.432 was found for BW-SCMC at the level of 1.47g of MCA, 188 min of etherification process and 48.5oC of etherification temperature with a desirability of 1.000. Whereas optimum DS of 1.141 was found for ES-SCMC at the level of 1.17g of MCA, 166.3 min of etherification process and 53.65oC of etherification temperature with a desirability of 0.967. III | P a g e Analysis of the triplicates synthesized BW-SCMC and ES-SCMC at the optimum conditions confirmed the effectiveness of optimization. The experimental values were found to be in close agreement with the predicted values confirming the predictability and validity of the model. The optimized SCMC had a yield of 1.58 g/g (BW-SCMC) and 1.31g/g (ES-SCMC) of BWC and ESC, respectively. The appearance of new bands around 1600 and 1412 cm‐1 in the FTIR spectra of SCMC samples showed efficient attachment of carboxymethyl groups to the cellulose chains. The XRD analyses of the SCMC samples showed a significant reduction in crystallinity with the main diffraction signal at 2θ = 20°. From the TGA, the Tmax of the synthesized SCMC ranged from 285‐296 °C. The BW-SCMC (DS: 1.432) exhibited better heat stability than ES-SCMC (1.141) and C-SCMC (DS: 0.87). The prepared BW-SCMC and ES-SCMC were evaluated as suspending agents in paracetamol suspensions in comparison with commercial SCMC (C-SCMC) at a concentration range of 1–4% (w/v). The resulting suspensions were evaluated for their sedimentation volume (%), degree of flocculation, viscosity, redispersibility and dissolution rate, and real time stability studies were performed for 3 months. The apparent viscosities of the formulations prepared with BW-SCMC and ES-SCMC were higher than those of C-SCMC. The flowability of the suspensions, at all concentration levels of the suspending agents were in the order of C-SCMC > ES-SCMC > BW- SCMC. At 1% and 2 % concentrations, BW-SCMC and ES-SCMC provided higher sedimentation volume than C-SCMC. At 3% and 4%, all exhibited comparable sedimentation volume (100%). Potassium dihydrogen phosphate (KH2PO4) employed as a flocculating agent increased the sedimentation volume of all suspension formulations at 1% and 2%. The redispersibility of BW- SCMC and ES-SCMC were better than C-SCMC at lower concentration. All prepared suspensions showed a release of greater than 85% of drug within 1 h. The results of stability studies showed that all suspension formulations were stable. From the findings, it can be concluded that BW- SCMC and ES-SCMC could be used as alternative suspending agents.Item Regulatory Requirements and Enforcement Practices for Importation of Medicines for Personal Use into Ethiopia(Addis Ababa University, 2023-07) Zellek,Mintwab; Gedif,Teferi(Prof.)Background: Evidence shows that some medicines imported for personal use are poor quality and counterfeited. In Ethiopia, although travelers import medicine for their personal use, little is known what medicines, and how frequently is being imported. Objectives: To assess importation patterns, regulatory requirements, and enforcement practice of medicine importation for personal use in Ethiopia. Method: A sequential exploratory mixed methods design was used to assess importation pattern, regulatory requirements and enforcement practices of personal medicine importation in Ethiopia. Secondary documents analysis and one-to-one interviews were used for data collection. Quantitative and qualitative data were analyzed using Microsoft Excel and thematic analysis approach, respectively. Results: Importing medicines for personal use have accelerated dramatically; records show that 56 travelers imported 151 medicines in 2020 and 398 travelers‟ imported 920 medicines in 2021. Releasing medicines without EFDA approval, gaps in the rules and regulations, shortage of some medicines and lack of coordination between key stakeholders were identified as contributing factors for the rise in the importation of personal medications. Conclusion: Importing medicines for personal use without a prescription is a growing concern in Ethiopia. The EFDA should strengthen the regulatory system; restructure existing law enforcement operations for the importation of medicine for personal use, and engage in high- level discussions with stakeholders.Item Assessment of Mobile-Based Vaccine Logistics Management Information System Implementation in Public Health Facilities of Gambella Region, Southwest Ethiopia(Addis Ababa University, 2023-09) Abebaw,Nigus; Mekonen,Zelalem Tilahun( MSc, Ass. Prof)Background: Ethiopia uses a combination of an integrated and interoperable information system to manage vaccines within Ethiopian Pharmaceuticals Supply Service’s (EPSS) supply chain system. Lack of access to reliable and timely data visibility for decision-making and poor vaccine management and efficiency are the challenges in Ethiopia. The mobile-based vaccine logistics management information system-(mBrana) implemented throughout Ethiopia for vaccine logistics information and inventory management. Objective: The aim of this study is to assess mobile-based vaccine logistics management information system implementation in public health facilities of Gambella Regional State. Method: Cross-sectional study design with sequential explanatory mixed data collection methods used in the study. Eighteen health facilities covered in the study and 44 respondents selected through random sampling technique. The quantitative data was analyzed by using descriptive and inferential statistics. Qualitative data analyzed thematically. Results: the analysis and reporting of mBrana has statistical significant effect on perceived usefulness(r=0.315, p=0.037) and usability(r=0.441, p=0.003) for informed decision making at five percent level. The quality of data with timeliness, completeness, and accuracy were 89%, 97%, and 90% respectively. The stock availability as compared with the past six months to the day of data collection visit was reduced 11.7%. The identified challenges for mBrana were administrative (lack of support, poor internet connection, phone damage, staff turnover, lack of ownership, low data package, electric power interruption) and technical challenges (skill gap, communication gap, system configuration challenge, lack of commitment, lack of skill transfer). Conclusion: Data use in mBrana level of agreement is high and has direct relation with perceived usefulness and usability of mBrana. The overall average data quality was 92%. Identified challenges were administrative and technical challenges. It is all important to give attention on boosting the availability vaccines via effective use of digital logistics management system like mBrana in all public health facilities of the region.Item Customs Clearance Practice and Related Challenges in the Ethiopian Customs Commission: a case of Pharmaceutical(Addis Ababa University, 2023-06) Taye, Kaleab; Cho, Denny (PhD); Teshome, Dawit; Coll, AngelicaBackground: Pharmaceutical at ports and/or custom stations need to be cleared in the shortest possible time due to their sense of urgency and requirement of special handling. However, the customs clearance procedure in most countries is time-consuming, leading to unnecessary delays and financial losses. In Ethiopia, there is a paucity of information about pharmaceutical customs clearance practice and related challenges. Objective: To assess pharmaceutical customs clearance practice and to identify challenges in the Ethiopian Customs Commission (ECC). Methods: The study was conducted in ECC from September 2019 to January 2020. A concurrent mixed methods design was employed. Quantitative data (using a structured questionnaire, and data abstraction formats), and qualitative data (using Key Informant interview guide) were collected at the same time frame. Quantitative data were analyzed using descriptive (percentage, frequency, mean and standard deviation) and inferential statistics (t- test and ANOVA). For the qualitative data, thematic analysis was applied. Results: Pharmaceutical transaction worth of $574,487,522 were cleared by the ECC in 2019/2020. Of these, more than half of the pharmaceutical were imported from Europe (57.2 %). Ethiopian Pharmaceutical Supply Agency (EPSS) (63%) was the major importer of the products. The overall mean score for customs and trade facilitation standards was 3.13 (±0.6). On the other hand, 2.85(±0.74) was the overall mean score for efficiency of pharmaceutical custom clearance. This study showed that Pharmaceutical Importers (PI), Local Manufacturers (LM) and EPSS face various challenges in dealing with customs clearance procedure. Some of these include: delays and interruptions in the electronic system (Electronic Customs Valuation System (ECVS)), gaps in valuation system (not being invoice based and inconsistent), and poor pharmaceutical handling, and delays in the inspection of pharmaceutical imports by EFDA officers. Conclusion: Most of customs and trade facilitation standards are not being applied in ECC custom stations and the overall pharmaceutical customs clearance process was found to be inefficient. As a result, EPSS and Pharmaceutical companies are facing numerous challenges and their operations are being affected negatively. Consequently, patients are forced to bear unnecessary costs incurred due to the system inefficiencyItem Assessment of Pharmaceutical Supply Chain Risk management: The Case of Ethiopian Pharmaceuticals Supply Agency(Addis Ababa University, 2021) Tamrie,Manaye; Mitiku,Shiferaw(PhD); Nitsche,Benjamin(PhD)Background: Supply chain risk management is the process of identification, assessment, mitigation, and monitoring of risks. Pharmaceutical suppliers and distributors face multiple risks that disrupt the supply of drugs interms of quantity, quality, and delivery at the right place and time to the right customer. Therefore, caution must be taken as health is critical and pharmaceuticals are unique. Objective: To analyze the pharmaceutical supply chain risks and assess the risk management practice of the Ethiopian Pharmaceuticals Supply Agency. Method: An explanatory and descriptive case study design was employed. Totally, 101 samples were involved in the study selected through purposive sampling technique. An interview guide, questionnaires, and risk checklists were used to collect quantitative and qualitative data from respondents. The Excel-derived failure mode and effect analysis template, and SPSS version 23 were used for the data analysis. Thematic analysis of qualitative data was also employed. Result: Eighty nine risks were identified and categorized into six groups. Among these, supply and demand side risks take the priority in affecting the supply chain operation. Inability to meet customer demand, lead time variability, and poor logistics performance of suppliers are under high risk score categories. Most of the respondents, 45 (44.6%), agreed that the risk management practice at Ethiopian pharmaceuticals supply agency is at its infancy. Risk identification methods being used are found to be risk estimation, previous risk assessment, and brainstorming sessions. The most applicable risk management tools are inventory optimization (29.9%), sales (22.4%), and operation planning tool (27.6%). The overall implementation of risk management strategies are below the average. Supply side (β = -2.171, P ˂ 0.020), process (β = -0.979, P ˂ 0.026), and control (β = -1.694, P ˂ 0.004) risks negatively affect the supply chain performance, while risk management practices (β = 6.440, P ˂ 0.002) affect it positively. ii Conclusion: Supply side risks took the primary position during prioritization followed by demand side and operational risks while environmental risks were at the least position. The overall risk management practice of the Ethiopian pharmaceuticals supply agency is weak. The level of implementation of risk management processes are low while the applicability of risk management tools are above the average level in the last 5 years history of the agency. Supply side, process, and control risks affect the supply chain performance negatively. However, supply chain risk management practices have a positive impact on performance. Recommendation: The Ethiopian pharmaceuticals supply agency should establish a separate team that primarily assess, analyze and control supply chain risks at all hubs. The agency should also be engaged in more scientific methods of risk identification methods like surveys, and risk assessment to identify, control, and minimize impacts of risks.Item Preparation, Characterization and Evaluation of Emulgel Formulation of Local Thyme Essential oil (Thymus Serrulatus Hochst. Ex Benth) for the treatment of Candida Albican skin infection(Addis Ababa University, 2023) Solomon, Atsede; Joseph, Nisha Mary (PhD); Molla,FantahunThe genus thyme is an aromatic evergreen shrub with many branches and a woody base found all over the world, but it is thought to have originated in the Mediterranean region of temperate zones. The genus Thyme is represented in Ethiopia by two endemic species, T. serrulatus and T. schimperi. T. serrulatus is found in Gondar, Bale, Tigray, Wollo, and Semen Showa. Traditionally, this plant has been used primarily to treat fungal infections. However, no research has been conducted to evaluate the plant's emulgel formulation for the treatment of candida albican skin infection. Therefore, the aim of this study was to prepare, characterize and evaluate emulgel formulations of local thyme essential oil (T. serrulatus) for the treatment of candida albican skin infection. The essential oil of T. serrulatus was extracted using a hydro-distillation method with a Clevenger type apparatus. Gas chromatography-mass spectrometry (GC/MS) was used to examine the chemical composition of T.serrulatus oil. Seven emulgel formulations with 2% T.serrulatus oil, various types and concentrations of emulsifying agents (Span 80, Tween 80), gelling agents (Na CMC and HPMC at 1%, 2%, 3%, and 4% concentrations), and 7.5% virgin olive oil and liquid paraffin as oil phases were prepared. The physical appearance (consistency, homogeneity, phase separation, and texture), pH, spreadability, extrudability, viscosity, swelling index, and drug content uniformity of the prepared formulations were characterized and evaluated. Following the selection of the best formula, it was tested for in vitro drug release, in vitro antifungal activity against Candida albicans ATCC using the disc diffusion method, skin irritation on rat skin, and three-month stability study. According to the GC/MS analysis, the extracted thyme serrulatus essential oil was light yellowish in color and contained 22 compounds. The essential oil's main constituents are thymol (36.92%), O-cymene (26.05%), carvacrol (19.15%), and -terpinine (8.24%). Seven of the prepared emulgel formulations (F3, F6, F7, F10, F11, F14, and F15) demonstrated acceptable physicochemical properties with creamy white to pale white color appearance and excellent homogeneity, consistency, texture, and pleasant odor. Furthermore, no phase separation or aggregates were observed. The pH of the formulations was within an acceptable range for skin. The viscosity, spreadability and extrudability were optimum for the better patient compliance. In both the blank and drug-loaded emulgel formulations, the swelling index was rapidly increased and maintained for 90 minutes. VI The drug content uniformity in five emulgel formulations was within the official pharmacopeia limit (F6, F10, F11, F14, and F15) 95%, 90.8%, 98.2%, 101.3%, and 97.5%, respectively. The thyme serrulatus oil emulgel drug release was good after 6 hour release time. Thyme serrulatus oil emulgel exhibited a strong inhibition zone (36 mm) of antifungal activity against the tested pathogen, a wider zone of inhibition than the marketed miconazol cream (28mm). The result of irritation test showed no edema and erythema. Thyme serrulatus oil emulgels maintained their Physico-chemical stability at 30 ±5℃ /65±5 RH and at 5 ±3 ℃ storage conditions. From this, the result of this study demonstrated the potential application of emulgel formulation of thyme serrulatus oil with acceptable physico chemical properties for the treatment of candida albicans skin infectionItem Assessment of Medicine Regulatory Performance In South - West Ethiopia: The Case of Ilu-Ababora Zone, Oromia Regional State(Addis Ababa University, 2023) Girma, Tesfahun; Habte, Bruck Messele(PhD); Fato,Abdulkadir WolyeiIntroduction: The implications of ineffective pharmaceuticals regulation is becoming a major problem worldwide. Therefore, in order to address this issue and provide access to high-quality medications, every country should meet the minimum standards of a functional pharmaceuticals regulation. Objective: - To assess medicine regulatory performance in Ilu-Ababora zone, Oromia regional state, south west Ethiopia Methods: A sequential mixed methods (quantitative method followed by qualitative research approaches) was conducted from July to September 2022 G.C. in Ilu-Ababora zone using document review, simulated client visit method and semi-structured interviews. The study participants were regulatory professionals and healthcare providers working in Zonal Health Office, selected Woreda Health Offices and both public and private medicine retail outlets including private clinics. The data was analyzed using descriptive methods for the quantitative part and thematic analysis for the qualitative part. Results: Majority 91.66% of retail outlets from the total 24 issued non prescribed antibiotics at three distinct demand levels. In Ilu-Ababora zone there were 3,944 human health related facilities to be inspected by the zonal health department regulatory teams in collaboration with each woredas regulatory teams. But, at the zonal health department there were only two inspectors. All the woredas except Mettu City Administration, which has two inspectors, has one or none inspectors assigned. They didn’t have separate vehicle as well as no budget breakdown for regulatory activities. The regulatory performance is currently very poor. Performance influencing factors like widening of control area, scarcity of resources, capacity building problem, information iv leakage, lack of attention from the stakeholders, communication-related issues, and lack of awareness from the society were identified. Increased circulation of unsafe products, compromising patient’s quality of care, and monetary costs were reported as major concerns. As important interventional tactics, sector experts suggested enhancing capacity building techniques, involving sector stakeholders, and strengthening the regulatory structure. Conclusion: Despite the availability of comprehensive medicine regulations in Ethiopia, the results of this study show that the enforcement of these regulations is weak and the way regulations are currently being implemented in this area is not very effective and is still in the early stages of development.Item Assessment of Inventory Management Practices of Essential Medicines for Mental Health in Public Hospitals of Addis Ababa, Ethiopia(Addis Ababa University, 2023) Wana,Yitbarek; Dejene,Michael (MD, MPH, MSc)Introduction: Mental health is a state of well-being in which an individual realizes his or her own abilities, can cope with the normal stresses of life, can work productively, and is able to make a contribution to his or her community. Even in settings like low- and middle-income countries where the burden from infectious and nutritional conditions remains overwhelming, at least 9% of the overall burden of disease is attributable to mental disorders. Global mental health has documented that effective interventions exist for the large majority of mental health disorders. However About two-thirds of people with diagnosable mental health disorders do not receive treatment. Objective: To assess inventory management practices of essential medicines for mental health at public health facilities in Addis Ababa, Ethiopia. Methods: A sequential mixed study was employed. A facility based quantitative method was conducted using checklist, structured and semi structured questionnaire followed by qualitative method to explain the challenges and opportunities. Microsoft Excel Spreadsheet and SPSS version 20 was used to encode and analyze the data. Spearman’s rho was used to determine the association between inventory management practice and performance. The critical value (p<0.05) was considered significant. Results: Of twenty six medicines of mental health included under this study 28% were considered vital by public hospitals and 42.5% available on the day of visit. The mean stock out and frequency of stock out was found to be 0.73 and 0.86 respectively with average stock out duration of 95 days within six months of study period. Chlorpromazine, olanzapine, sertraline, clonazepam, Lithium carbonate, Lamotrigine, Phenobarbitone and promethazine tablets were out of stock at least once at each facility. The mean wastage rate of medicine for mental health was 4.5% with a value of 494,231.40 birr within six months of review, irregular consumption was the major reason for expiry. Conclusion: Essential medicines of mental health were routinely not available in public hospitals and the practice was found poor and different between categories of medicines and from one public hospital to the other. Antipsychotics were found to be most available and anticholinergics were not found in any of the facilities under study on the day visit. Second generation antipsychotics and antidepressants were most frequently stocked out items. The responsiveness by the supplier was poor as it was not able to refill those items whenever the facilities requested nevertheless of frequent stock outs, hence stock out at the source was the major reason for stock out.Item Optimal Pharmaceutical Replenishment Policy: The Case of Selected Health Centers in Addis Ababa(Addis Ababa University, 2023) Demissie,Bezawit Negash; Rothkopf,Alexander(PhD); Tilahun,Zelalem(Ass. Prof.)Background: The primary goal of inventory management is to establish a replenishment policy that informs when and how much to order and how to maintain an appropriate stock level while optimizing various tradeoffs, such as carrying and re-ordering costs. The need for the healthcare sector to reduce costs has motivated many hospitals to adopt new technology to enhance existing operations. Since 2009, Integrated Pharmaceuticals Logistics System (IPLS) has been used in Ethiopian public health facilities to manage inventory. To the investigator's knowledge, the optimality of the replenishment system to the respective health facilities was not well investigated. Objectives: This study aimed to determine an optimal replenishment policy for managing inventory for selected health centers in Addis Ababa, Ethiopia. Methods: A multiple case study design was used in ten selected health centers. This study primarily uses quantitative data from the pharmacy stores’ database system. Three years of data were extracted from the digital bin card and entered into the pre-tested excel-data extraction tool. Once the data was sufficiently cleaned, a descriptive statistic and correlation using Microsoft Excel 2019 and IBM SPSS version 26. A simulation-optimization approach was used to show the current total inventory cost and develop an optimal replenishment policy. Result: The monetary amount of the program medicines issued from the health centers within three years was 93,922,330.05 ETB, in which Anti-retroviral treatments took the highest percentage, 78.69%, followed by Mother and child health products, 10.8%. When the demand frequency is observed, there is zero demand 50% of the time; this shows high intermittent demand. Demand variability significantly correlates (𝑟 = 0.84) with the health centers' total cost. The lowest total cost was observed in the replenishment policy of every other month with a target customer service level of 90% and realized customer service level of 92.7%. The highest total cost was observed in the replenishment policy of every month with target customer service level of 99% with a total cost of 141,706.4 ETB with realized customer service level of 99.4%. Conclusion: The analysis showed the segregation of products based on their characteristics has a potential advantage since the demand pattern significantly varies among products. The study showed the current IPLS method of determining order up to level resulted in less customer service level and increased the likelihood of overstock. Based on the simulation-optimization model, the less costly replenishment model is 90% target customer service level and every other month replenishment, but it is important to set a target service level based on product characteristics and integrate segregation of products, including the price and demand variability to achieve the optimal replenishment. Recommendation: Health centers may integrate characteristics of products, financial parameters, longer historical data and standard deviation of demand to identify order quantity and review period. The findings from this study can be used to commence further investigation in the fitness of IPLS inventory control system by considering other alternatives with technical and financial feasibility.Item Pharmacy Professionals’ Acceptance of Electronic Health Commodity Management Information Systems: An Evaluation of Health Facilities in Addis Ababa(Addis Ababa University, 2023) Getachew,Nardos; Eshetu, Eskinder(PhD)Introduction: The electronic Health Commodity Management Information System (e- HCMIS), also known as DAGU, was developed locally to help in improving the health commodity supply chain in Ethiopia. However, there is paucity of information on the acceptability of the system for the end users. Objective: To investigate pharmacy professionals’ acceptance of the e-HCMIS and identify its determinants in public hospitals of Addis Ababa. Methods: A facility-based cross-sectional descriptive study, following a sequential explanatory mixed method approach with both qualitative and quantitative methods of data collection, was done. The study included 10 public hospitals in Addis Ababa. The quantitative approach used structured questionnaire based on extended Technology Acceptance Model 3 (TAM-3). Key informant interviews were done to clarify and contextualize the quantitative findings. Structural equation modeling with maximum likelihood estimation were used to analyze quantitative data. Qualitative interviews were thematically evaluated. Results: There were a total of 237 survey respondents, response rate of the study was 96.19%. TAM-3 explained 49.2% of the variance of behavioral intention to use e-HCMIS. The study found that Perceived Usefulness and Perceived ease of use were significant predictors of behavioral intention. Job relevance was a predominant factor for perceived usefulness; perceived enjoyment and computer anxiety were predominant factor for perceived ease of use. The qualitative study revealed perceived usefulness, management support, ownership and perceived ease of use were the major determinants of behavioral intention. iii Conclusion and Recommendation: Given the importance of perceived usefulness and perceived ease of use, including a more user friendly design and scaling up the level of application of the system are recommendedItem solation, Evaluation and Optimization of Waste Derived Citrus Aurantifolia Peel Pectin as a Polymer in Furosemide Floating and Bioadhesive Matrix Tablet Formulation(Addis Ababa University, 2023) Abdela,Ebrahim; Belete, Anteneh(PhD); Mulualem,YohannesThe Citrus aurantifolia (Christm) Swingle species can be found in many parts of the world including the subtropical and tropical areas. It is a small shrubby tree, about 5 m length and has fruit has globule to oval nearly 3-6 cm diameter with a color range from light yellow to purple. Some studies revealed that citrus waste derived pectin- becoming promising way for based gastro- retentive (floating and bioadhesive) drug delivery systems formulation due to pectin’s economic, environmental and health related benefits. However, the floating and bioadhesive ability of the citrus aurantifolia peel pectin is not yet established. The bioavailability of furosemide is irregular through oral route and subjected to inter- or intra-subject variability. Hence, on the basis of its physico- chemical properties, it is a candidate drug for gastro-retentive formulations. Therefore, this study aimed to evaluate the potential of citrus Aurantifolia peel pectin as a polymer for preparing floating and bioadhesive matrix tablet using furosemide as a model drug. The citrus peel pectin was extracted from local citrus aurantifolia tree fruit peel using hot water extraction technique and characterized for several physicochemical properties such as the presence of carbohydrate, loss on drying, total ash, pH, water solubility index, swelling power, relative solubility, moisture sorption-desorption pattern, viscosity, powder flow properties and its compatibility with the model drug were investigated. Wet granulation method was employed to prepare the furosemide granules and the prepared granules were evaluated for particle size and distribution, bulk and tapped densities, compressibility index and Hausner ratio, angle of repose, flow rate, and the friability of the formulated tablets were evaluated. Other tablet quality parameters including friability, hardness, thickness, diameter, weight variation and content uniformity were assessed and in acceptable pharmacopeial standard. Based on the preliminary investigation, the pectin (10-40%) and effervescent agent (NaHCO3) (5-20%) concentrations were significantly affecting the response variables (p value < 0.05) such as floating duration (FD), bioadhesive strength (BS), swelling index (SI), drug release at 1 hr (DR1hr) and drug release rate (DRR)). Hence, further optimization study was conducted using central composite design (CCD) approach of design-expert 13 software. Both numerical and graphical optimization techniques were used for optimization. The Citrus aurantifolia tree fruit peel yielded 34.4% (w/w) purified pectin with light yellow color. Its pH and ash values were 4.6 and 2.29%, respectively. It showed solubility in hot water. The equivalent weight, methoxy content, anhydronic acid, and the degree v of esterification were 81.5, 13.84, 91.68, and 85.49, respectively which showed high methoxy pectin. The purified pectin powder had a Carr’s index of 36.6, Hausner ratio of 1.36 and angle of repose 32.78o which necessitates to conduct wet granulation technique. The compatibility study using FTIR and DSC analysis revealed that furosemide and citrus peel pectin were compatible. The drug release kinetic analysis of 13 formulations as per the CCD revealed best fits for Higuchi model with diffusion and erosion release mechanisms. The optimization results indicated that quadratic model was selected for swelling index and linear for the other responses. The adequacy of the model was evaluated using analysis of variance (ANOVA). Accordingly, the model provided an optimum formulation at 22.3% of pectin concentration and 5 % of effervescent agent. Under this condition, the software predicted floating duration (14.07 %), bioadhesive strength (28.57gm), swelling index (254.08%), drug release at 1hr (27.86%) and drug release rate (28.045 % / h-1/2). The optimization result predicted the optimized value of the independent variables to achieve desired responses was evaluated. The validity of this optimum formulation was confirmed experimentally. Based on the experimental studies, the validity of the model or software prediction was confirmed and the relative error are less than 5%. The flowability of the granule of optimized tablet was found excellent as the angle of repose was found to be <300 while the Carr’s and Hausner ratios were determined as < 10 and < 1.11 respectively. In conclusion, the results of this study enable to suggest that waste-derived citrus pectin can be used as an abundant alternative pharmaceutical excipient in the formulation and manufacture of floating and bioadhesive matrix tablets, leading to the formulation of an optimal floating and bioadhesive formulation