Pharmaceutics

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Validation of Tablet Manufacturing Process in the Ethiopian Pharmaceuticals Manufacturing Factory (EPHARM)
(Addis Ababa University, 2000-05) Mossisa, Lemu; Gebre-Mariam, Tsige (Prof.)
Process validation may be defined as a systematic approach to identi fyi ng, measunng, evaluating, documenting and re-evaluating a series of critical steps III the manufacturing process that require control to ensure a reproducible final product. The approach is based on the principle that "quality is not tested into a product but rather is built into a product". It is with this principle in mind that this work has been designed and conducted. The validation study was limited to the tablet manufacturing process in the Ethiopian Pharmaceuticals Manufacturing Factory (EPHARM). Three tablet products were selected, namely, Chloroquine phosphate 250 mg, Paracetamol 500 mg and Frusemide 40 mg for the study. Chloroquine phosphate, is a highly water-soluble salt with little or no compressibility problems. Paracetamol is moderately soluble in water with a high tendency to capping. Frusemide is practically insoluble in water which may pose problems in drug release. In this study, the manufacturing facility and equipment, the raw material acquisition and testing procedures, the tablet manufacturing process, and the in-process control procedures were evaluated. Samples of the in-process materials and the fini shed products were taken and tested for compliance with quality specifications. The results of the study suggest that the proportion of fines in granulations of some of the products was excessive (chloroquine phosphate). Measurements of angle of repose indicate that the granulation bulk density, flow and surface characteristics were generally good. One-way analysis of variance (ANOY A) revealed that there was significant vari ation 111 the granulation moisture content of all of the products tested. Paracetamol tablets lacked the shiny smooth appearance expected of plain, compressed tablets. High hardness variation has been observed in some products (paracetamol, frusemide) but thickness was within the specification in all cases. Two batches of paracetamol capped and, hence, failed friability test specifications. The tablets complied with the official weight variation and content uniformity specifications, but the range need to be narrowed through the use of internal specifications. Tablets of all of the products tested disintegrated within the specified time. Dissolution rate was within the official requirements in all cases. Complete in vitro drug release (90% or more of label claim) was observed in all cases, but the optimum goal of achieving 90% drug release below 30 min was not attained particularly with frusemide and in some batches of paracetamol. Standard operating procedure (SOP) was not strictly followed during some of the unit operations. The document (batch manufacturing record) was lacking the necessary details required of such a document. For example, mixing time and mixing intensity in mixers, drying time and temperature in dryers, machine speed, compression force etc. in tablet presses were not clearly stated. No in-process control activity was observed at the granulation stage and there were no quality specifications available for the granules. Machine cleaning and maintenance procedure and documentation was lacking. Personnel training was inadequate. Generally the GMP requirements in the area of facility and equipment, personnel, process validation, documentation, etc. are not fulfilled.
Standardisaltion and Tablet Formlulatilon of the Extracts of the Seeds of Glinus lotoides
(Addis Ababa University, 2000-06) Endale, Abebe; Gebre-Mariam, Tsige (Prof.)
Glinus lotoides Linne, locally known as "Mettere" is an ailliual herb, the seeds of which are traditionally used as anthelminthic for the prevalent tape worm infection. The taenicidal activity has been attributed to the saponins present in the seeds. This study reports on the development of suitable extraction and purification methods of the seeds of the plant; the development of analytical methods for quantification of the saponins in the crude extracts; the physico-chemical characterisation of the extracts; and tablet formulation thereof. Extraction and purification methods to obtain "total saponins" of G. lotoides were developed and the purified extract (i.e., total saponins) was used as a standard for quantitative determination. Sensitive colourimetric and UV -spectrophotometric methods were developed and ~-escin, a mixture of triterpenoidic saponins obtained from Aesculus hippocastanum, was used as a control standard. For the colourimetric assay method, the official German Pharmacopoeia (DAB) method of determination of ~-escin was adopted with slight modification. In this, saponins were reacted with ferric chloride in acetic acid: sulphuric acid (1: 1) and the red-coloured complex formed was measured at 540 and 409 nm for ~-escin and saponins of G. lotoides respectively. Linear regression of the calibration curves yielded equation Y = 6.6314X - 0.0279 (r = 0.9983) for ~-escin and Y = 12.669X + 0.0456 (r = 0.9993) for saponins of G. lotoides at concentrations ranging from 0.02 to 0.12 mg/ml and 0.01 to 0.06 mg/ml, respectively. XIII Pre-derivatization of saponins with 10% acetic acid in 0.1 N HCI rendered them UVactive and absorption was measured at 238 nm. Linear regression of the calibration curve yielded an equation of Y = 7.9514X - 0.0536 (r = 0.9983) at concentrations ranging from 0.02 to 0.12 mg/ml. Both methods showed comparable and reproducible results on identical samples and were employed for standardisation of the extracts of the seeds of G. lata ides. Physico-chemical properties of the powdered extracts of the seeds such as particle size and distribution, morphology, water sorption pattern, densities, flow properties and compaction profiles were investigated. Based on the density results, properties, namely, porosity, consolidation index (Carr's index) and Hausner ratio were calculated. The effects of some extraction processes, such as extracting solvents and methods of extract drying, on the physical properties of the extracts were investigated and a suitable solvent system and drying method were determined. Based up on the results of the preformulation studies, the most suitable extract of the seeds of G. la/aides (570 mg of Extract A) was formulated and compressed into 1.15g oblong tablets (having long and short diameters of 20.1 and 8.2 mm respectively). The effects of types of filler/binder, disintegrants and compression force were investigated. Tablet properties such as hardness, disintegration time and friability were evaluated and suitable tablet formulation was developed.
Evaluation of Local Gum of Acacia Polyacantha as a Binder in Tablet Formulations
(Addis Ababa University, 2002-06) Aklilu, Tegegne; Gebre-Mariam, Tsige (Professor); Ibrahim, Sayed (Professor)
Acacia gums are dried gummy exudates obtained from the stems and branches of acaica spp. (fam. Leguminosae). A. senegal is the source of most gum arabic of international trade and it finds wide applications in pharmaceutical, food and cosmetic industries. Other African acacia species of economic importance include A. seyal, A. drepanolobium and A. polyacantha. In this study, a local gum of A. polyacantha was evaluated as a tablet binder. Paracetamol and chloroquine phosphate were used as model drugs. The physico-chemical properties of the purified gum, and its rheological properties were investigated. The gum was found to have similar properties to Acacia BP (odourless, white to yellowish brown, glassy, no tannins, no starch or dextrin present and moisture content of 11.6%). It exhibited Newtonian flow up to 40% w/v solution but less viscosity than Acacia BP. Granules prepared with different concentrations (5 - 30% w/v for paracetamol and 5-20% w/v for chloroquine phosphate) of the gum mucilage were characterised for particle size distribution, bulk, tapped and true densities, friability and flow properties. The granules were mixed with Ac-Di-SolÒ (4%) and magnesium stearate (0.5%) and compressed into tablets at different compression forces. The optimum binder concentration (X1) and compression force (X2) (independent variables) of both substances (paracetamol and chloroquine phosphate) were investigated using 22 factorial design taking crushing strength (H), disintegration (DT) and friability (Fr) as response variables. Polynomial equations were generated for the responses (H = 84.175 + 26.825X1 + 33.375X2 + 5.625X1X2; DT = 9.24 + 8.38X1 + 4.59X2 + 4.45X1X2; Fr = 1.9725 – 0.7775X1 – 1.1225X2 + 0.6275X1X2 for paracetamol and, H = 118.8 + 12.35X1 + 48.05X2 – 1.7X1X2; DT = 8.375 + 1.125X1 + 3.875X2 – 0.375X1X2; Fr = 1.08 – 0.22X1 – 0.42X2 + 0.08X1X2 for chloroquine phosphate). Surface response curves and contour plots were constructed and the xi v optimum regions determined by superimposing the contour plots. The optimum values were re-transformed using the equation: Trans = [2A – (Max + Min)]/ Max – Min, where Trans is the transformed value, A is the actual value of the factor being transformed, and Max and Min are the maximum and the minimum values in the range of the factor being transformed, respectively. Granules of the optimum formulations (6.21% w/w of binder for paracetamol, and 1.386% w/w of binder for chloroquine phosphate) prepared had mean bulk densities of 0.41 and 0.508 g/ml, tapped densities 0.474 and 0.584 g/ml, Carr’s indexes of 13.58 and 13.01% and Hausner ratios of 1.16 and 1.15 for paracetamol and chloroquine phosphate, respectively. Tablets compressed at compression force of 14 KN (paracetamol) and 16 KN (chloroquine phosphate) were compared with predicted values (H: 122 and 119N, DT: 15 and 8.5 minutes and Fr: 0.6 and 0.9% for paracetamol and chloroquine phosphate, respectively). Tablets prepared with the gum showed H of 132 and 116N for paracetamol and chloroquine phosphate, respectively, and Fr of 0.9% for both substances. For comparison purposes, chloroquine phosphate tablets were prepared with 5% w/v PVP solution and H values of 122N and Fr of 0.9% were obtained. The DTs of the tablets made with the gum were 13 and 9.3 minutes for paracetamol and chloroquine phosphate, respectively. Dissolution profiles of the tablets were within the acceptable ranges (³ 80 and ³ 75% of drug release in 30 and 45 minutes for paracetamol and chloroquine phosphate, respectively). The respectiveT50s were 5 and 8 minutes. From the foregoing, it can be concluded that gum of A. polyacantha can be used as an alternative binder in tablet formulations.
A Prospective Study on Self-Medication Practices and Consumers Drug Knowledge in Addis Ababa
(Addis Ababa University, 2002-06) Andualem, Tenaw; Gebre-Mariam, Tsige (Professor)
Background: Health and disease exist in a continuum. Self-care is as old as illness if not as humans. Self-care is a lay behavioural response of individuals to promote or restore their health. One form of self-care is self-medication. Drugs are central to self-medication. Although there are arguments for and against self-medication, its contribution to promote health, and prevent and treat diseases is beyond doubt. Self-medication is the selection and use of medicines by individuals to treat self-recognized illnesses or symptoms of illnesses. Socio-demographic and socio-economic variables affect self-medication. In this study, an attempt has been made to assess self-medication practices with modern drugs and consumers drug knowledge in Addis Ababa. Methods: A multi-stage stratified sampling of drug retail outlets and drug consumers (actual drug users and messengers) was designed and used. Structured questionnaires to assess prospective self-medication practices and consumers drug knowledge were employed. The data was analyzed using Epi Info Software. Results and Discussion: The respondents represented all socio-demographic characteristics such as age and gender (the proportion of males was twice that of females); education levels and occupation; religion (the majority being Orthodox Christians) as well as pregnant and breast-feeding women. The most frequently reported illnesses that prompted drug consumers for self-medication were found to be gastrointestinal (GI) diseases, headache/fever and respiratory tract infections (RTIs). More than 30% of illnesses/symptoms of illnesses were of less than 24 hours duration and more than 40% between one and seven days. The most common reasons for self-diagnosis and self-medication were non-seriousness of the diseases and prior experience about the drugs. More than 50% of the drug consumers requested drugs xi by specifically mentioning the names of the drugs and one-fifth of them by telling their illnesses/symptoms of illnesses. The most frequently requested category of drugs were analgesics/antipyretics (more than 30%), antimicrobials (more than 25%) and gastrointestinal drugs (more than 17%). Assessment of drug knowledge revealed that drug consumers know not only the names of OTC drugs but also other potent drugs, indicating widespread use of the latter. For example, among the top fifteen frequently recalled drugs five were antimicrobials. Drug consumers had also some dosage form preferences, the highest being injections and tablets for messengers and for actual drug users, respectively. Multivariate analysis showed that there is association between illness/symptoms of illness with the duration of illness and source of advice/information for self-medication (p value less than 0.05). Strong association (p value = 0.0000) was observed between the source of advice/information and the frequently requested category of drugs, some socio-demographic variables with sources of advice/information, knowledge of drugs, and the frequently requested category of drugs. Conclusion: Self-medication is widely practiced by all categories of respondents for a wide range of illnesses/symptoms of illnesses. More than 100 different types of drugs were used for self-medication. Although there is some apparent consumers drug knowledge, it is suggested that the public has to be educated on the type of illnesses to be self-diagnosed and the type of drugs to be self-medicated. It is only then that responsible self-medication prevails to promote health and prevent/ treat illnesses.
Phytopharmaceutical Studies of Some Selected Medicinal Plants Locally Used In the Treatment of Skin Disorders
(Addis Ababa University, 2004-01) Tadeg, Hailu; Gebre- Mariam, Tsige (Professor); Asres, Kaleab (PhD)
In this study, eight species of traditionally used medicinal plants namely Acokanthera schimperi (Apocynaceae), Calpurnia aurea (Fabaceae, Leguminosae), Kalanchoe petitiana (Crassulaceae), Lippia adoensis (Verbenaceae), Malva parviflora (Malvaceae) Olinia rochetiana (Oliniaceae), Phytolacca dodecandra (Phytolaccaceae) and Verbascum sinaiticum (Scrophulariaceae), were screened for antimicrobial activity against different strains of bacteria and fungi which are known to cause various types of skin infections. Among these plants, L. adoensis and O. rochetiana, which showed better antimicrobial activity in the initial screening test, were selected for further investigations. Fractionation and antimicrobial activity tests of the fractions, anti-inflammatory activity tests, phytochemical screening, evaluation of topical formulations, and preliminary standardization studies were carried out on the two species of plants. The results of the initial antimicrobial screening test indicated the potential of these herbal drugs in treating bacterial and fungal infections of the skin. Almost all species of plants were found to have activity on at least one strain of bacteria and/or fungi. This might justify their claimed uses in the treatment of various skin disorders the majority of which are of infectious origin. Among the different fractions (petroleum ether, chloroform, acetone and methanol) tested for antimicrobial activity, the non-polar fractions were found to be more active than the polar fractions. The phytochemical screening tests carried out on L. adoensis and O. rochetiana indicated the presence of tannins, flavonoids and saponins in both species of plants. The antiinflammatory activity test results however have indicated that the two species of plants do not have demonstrable anti-inflammatory activity. xii Performance evaluation of topical formulations of the crude extracts in different vehicles revealed that extracts incorporated into creams (especially the hydrophilic ones) are superior in performance than those incorporated in to ointments. In addition, crude extracts formulated into water soluble ointment (PEG ointment) demonstrated higher performance compared to lipophilic ointments. The most lipophilic formulation of the crude extracts, petrolatum ointment, was found to be devoid of any activity against all the tested strains of bacteria and fungi indicating that the active compound(s) could not be released from this vehicle. Although evaluation of the quality of the two herbal drugs was not possible due to absence of published data for comparison, the most commonly employed standardization/quality control parameters including ash values, solvent extractable matters, loss on drying and TLC fingerprints were determined for the two herbal drugs in an attempt to provide such base line data as an indication of their quality attributes.
Ethnobotanical and Ethnopharmaceutical Studies on Medicinal Plants of Chifra District, Afar Region, North Eastern Ethiopia
(Addis Ababa University, 2004-01) Seifu, Tesfaye; Gebre-Mariam, Tsige (Professor); Asres, Kaleab (PhD)
Medicinal plants have not been well studied, tested or documented in Afar region, North Eastern Ethiopia. Most of the information is still in the hands of the traditional healers. A study was carried out during Nov.2002 – May 2003 to explore ethnobotanical information on the use of medicinal plants by Afar people in 13 rural communities of Chifra District, Afar Region, North Eastern Ethiopia. Based on the information found from ethnic leaders, 29 traditional medicine practitioners were interviewed by using pre-tested semi structured questionnaire. A total of 70 plant species were reported for their medicinal use in the district. Of these, 33 were fully identified by their botanical name, 10 at generic level and 27 couldn’t be identified and were recorded only by their vernacular names. 15% of the identified species belong to the family Fabaceae. Among 144 ethnoformulations reported, the majority were liquid preparations followed by unprocessed herbs and powder. The most widely used solvent to prepare the formulations was water. Size reduction, extraction and filtration were the most commonly employed unit processes in the formulation. Intranasal route of administration was frequently used next to oral route. Polyherbal preparations were common in order to have synergistic or summation effect. Although there is difficulty of determining accurate dose, the practitioners have an idea of dose and frequency of herbal preparations. Side effects are reported only for Aloe sp in therapeutic dose. Most of the oral herbal drugs are contraindicated for pregnant women. The practitioners have no idea of drug interactions and shelf life of the reported plant species. The data were analyzed using the concept of healer consent in order to identify culturally important medicinal plants. The medicinal uses of the plants were grouped into 9 disorder categories to have the factor of informant’s consensus (Fic) for each group. Accordingly, snakebite had the highest value (0.53) indicating the dependence of the practitioners on certain plants for the indication. The most frequently x i recorded medicinal plants of the Afar people were Aloe sp. used for the treatment of “Urribaqla”, malaria, abdominal cramp, TB and pasterlosis; Acalypha sp. for snakebite, blackleg, anthrax, “Barelitta”and impotence. The medicinal plants were assessed using published phytochemical and pharmacological data. Of the fully identified 33 medicinal plant species, the claimed medicinal uses of the six were in good agreement with other similar studies and pharmacological activity tests reported elsewhere. The medicinal uses of most of the reported plant species have not been documented in other parts of the country. This study underlines the need for further exploration of ethnobotanical information in the region and the results will be used as a basis for subsequent studies on pharmacology, phytochemistry and toxicology of medicinal plant.
Studies on Extracts of Some Medicinal Plants Traditionally Used for Dermatological Disorders in Ethiopia
(Addis Ababa University, 2004-02) Messele, Bruck; Gebre-Mariam, Tsige(Professor); Gamal, Mohammad (PhD)
Key words: traditional medicine, medicinal plants, antimicrobial activities, anti-inflammatory test, skin sensitization test, topical formulations. The majority of the populations in the developing world rely on traditional medicine for their primary healthcare needs. Herbal therapy predominates in traditional medical practices as well as in complimentary/alternative medicine practiced in the developed world. Among the indications where traditional herbal medicines are used, skin and skin related disorders, which also happen to be common diseases in the communities, rank among the top. This study had the objective of evaluating the extracts of four medicinal plants traditionally used for skin diseases, namely Inula confertiflora, Clematis simensis, Zehneria scabra and Pycnostachys abyssinica, for some of their claimed activities by both in vitro and in vivo methods. The 80 % methanol extract of the dried, ground plant materials was prepared. The plant extracts were then tested for antimicrobial activity against common bacterial and fungal pathogens by the agar well diffusion method. Furthermore, the 80% methanol extract of I. confertiflora was subjected to minimum inhibitory concentration (MIC) determination, in vivo studies such as antiinflammatory and skin sensitization tests as well as in vitro tests such as preliminary screening for the presence of some plant constituents, TLC analysis, and evaluation of topical antimicrobial formulations of the plant extracts. The results of the study indicated all of the plant extracts to exhibit antimicrobial activities against one of the most common bacterial pathogens, namely Staphylococcus aureus (ATCC). x Although these activities were not impressive especially as compared to the positive control used, they lend some credibility to the traditional uses of the plants. Good antifungal activity was demonstrated by one of the plant extracts (I. confertiflora) against Trichophyton mentagrophytes, which was further corroborated by the agar dilution method. I. confertiflora (80% methanol) extract proved to exert a good anti-inflammatory activity at a dose of 1000 mg/kg but not at a lower dose (500 mg/ml) in the carrageenan-induced paw edema test. These activities support the traditional use of this plant. Furthermore, the 80% methanol extract of I. confertiflora, was not found to be a skin sensitizer in the mouse ear swelling test as opposed to its petroleum ether counterpart, which demonstrated a strong sensitizing property. Some secondary metabolites such as sesquiterpene lactones and flavonoids were detected, which may be responsible for some of the demonstrated pharmacological activities of this plant. Evaluation of topical formulations of the 80% methanol extract of I. confertiflora demonstrated that the hydrophilic formulations exhibited higher antimicrobial activities compared to the lipophilic formulations. The activity of the hydrophilic formulations against T. mentagrophytes was comparable to the commercially available antifungal products tested. These bases could thus be used as a starting point for further formulation studies.
In-Vitro Comparative Evaluation of Different Co-Trimoxazole Tablet Products Obtained From Drug Retail Outlets in Addis Ababa
(Addis Ababa University, 2004-02) Assefa, Haymanot; Gebre-Mariam, Tsige (Professor); Ibrahim, Seid(Professor)
Evaluation studies provide a means of identifying quality differences between same products obtained from various manufacturers and quality evaluations are crucial in the era of increasing resistance to antibacterial agents The introduction of trimethoprim in combination with sulphamethoxazole constitutes an important advance in the development of clinically effective antimicrobial agents. In much of the world the combination of sulphamethoxazole with trimethoprim in the proportion of 5 to 1 is known as Co-trimoxazole. Co-trimoxazole has been used in a diverse range of infections due to sensitive bacteria and is widely prescribed for various indications. By virtue of sequential blockade of microbial folic acid synthesis the antimicrobial combination has excellent in vitro inhibitory activity against many common respiratory and urinary tract pathogens, as well as many nosocomial-infecting strains. In patients infected with the human immunodeficiency virus (HIV), trimethoprim-sulphamethoxazole provides prophylactic and therapeutic potency against Pneumocystis carinii but at the risk of side effects. Trimethoprim-sulphamethoxazole (TMPSMX) is also used for treatment of pulmonary and disseminated nocardiosis and some forms of Wagener’s granulomatosis, as well as for prophylaxis of spontaneous bacterial peritonitis. Bacterial resistance to trimethoprim-sulphamethoxazole is a rapidly increasing problem and is exacerbated by use of substandard products. In this work, it is aimed to evaluate the physical properties and the dissolution profiles of trimethoprim-sulphamethoxazole tablets produced by ten different manufacturers and are obtained from drug outlets in Addis Ababa. X I I Accordingly, the different tablets were evaluated for physical properties (Diameter, thickness, shape, hardness, friability and disintegration time) and their dissolution profiles were compared by the USP XXVI paddle method. The tablets investigated in this study could roughly be grouped as those, which exhibited, delayed drug release and those, which released the drug contained immediately. The tablets evaluated in this study differed in many of their physical properties. The average weights ranged from 502.41mg (Bactrim) to 709.98mg (Cotrimol), 480mg being the expected strength of the combination. The mean disintegration times ranged from 0.17 (±0) minutes (Cotrimoxazole) to 13.05 (±5.24) minutes (Lagatrim). Nine of the tested products gave an assay value above the lowest limit (93%-107%) specified in the pharmacopoeia. Assay values greater than the upper limit for sulphamethoxazole was obtained with four of the evaluated products. One product gave an assay value greater than the upper limit for both sulphamethoxazole and trimethoprim. Most of the tablets released the drug contained in an increasing fashion from the 5th minute to the 60th minute with varying proportion of increment. Products obtained from Europe released most of the drug within the first 5 to 10 minutes. More than 90 % of trimethoprim is released within 5 minutes from Bactrim and Septrin and with in 10 minutes from Lagatrim and Deprim. While Lagatrim and Septrin released more than 90 % of their Sulphamethoxazole within 10 minutes, Bactrim and Deprim released their Sulphamethoxazole within 20 minutes. However the European X I I I and the non-European products differed significantly in their sulphamethoxazole release. Both products showed a comparable trimethoprim release pattern. All of the tested products released more than 90% of the trimethoprim after one hour, ranging from 92.81%-Cotreich to 111.77%- Septrin. The very long t90% values of Cotreich and Cotrimol (60 & 45minutes respectively) for trimethoprim, the very long t50% & t90% values of Cotreich (38 and >60minutes respectively) for trimethoprim and sulphamethoxazole, and the very long t90% values of Cotreich, Cotrimol and Kanprim (>60 minutes) for sulphamethoxazole indicate that these products could result in lower rate and extent of bioavailability in the body. Similar problems could be encountered with the relatively long t90% values of Cotrimoxazole (45minutes) and Oriprim (40minutes) for Sulphamethoxazole. The smaller amount of sulphamethoxazole and trimethoprim released from products with delayed release could compromise the in vivo efficacy of these tablets.
Synthesis and Antimicrobial Activity of Triphenyltinbenzoate Aniline Complex
(Addis Ababa University, 2008-04) Zewdie, Berhan; Choudhury, M.K.(Professor)
Triphenyltinbenzoate and triphenyltinbenzoate aniline complex had been synthesized and characterized on the basis of infrared, mass and nuclear magnetic resonance (1H and 13C) spectral studies. The synthesized compounds had sharp melting point which indicated the purity of the compounds. The antimicrobial activities of the synthesized compounds were tested against six different pathogenic microorganisms; Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pyogenes, Aspergillus niger and Candida ablicans in vitro. The results indicated that the synthesized compounds exhibit a higher activity against Escherichia coli, Streptococcus pyogenes, Pseudomonas aeruginosa and Candida ablicans than the starting compound. The results also indicated that the compounds did not exhibit any activity against Aspergillus niger at concentration as high as 200 μgml-1.
Evalva Tion of the Diuretic and Analgesic Activities of the Rizomes of Rumex Abyssinicus Jacq in Mice
(Addis Ababa University, 2008-10) Mekonnen, Teshale; Fngidawork, Ephrem (PhD)
Rumex abyssinicus Jacq (Polygonaceae) is a widely spread medicinal plant used traditionally for treatment of several ailments, including hypertension, inflammatory and painful conditions. The present study aimed to examine the diuretic and analgesic activities of aqueous and 80% methanol extracts of the rhizomes of the plant at different doses in mice. To this effect, negative controls were orally treated with distilled water (DW) or Tween 80(4%) (TW80), solvents used for reconstitution of the extracts. Positive controls were treated with furosemide (10 mglkg) (FrIO) for diuretic test or aspirin (100 mg/kg) (ASA100) and morphine (10 mg/kg) (MIO) for acetic acid-induced writhing and hot-plate analgesic studies, respectively. For the diuretic study, treatment groups received an oral dose of SOO mgikg (RASOO), 7S0 mglkg (RA7S0) or 1000 mg/kg (RA1000) of the aqueous extract or 2S0 mglkg (RM2S0), SOO mg/kg (RMSOO) or 7S0 mglkg (RM7S0) of 80% methanolic extract. Urine volume was then measured at different time (1,2, 3, 4, and S h) and the urinary Na+, K+ and cr also measured at S h. For both analgesic tests, 2S0 mglkg (RM2S0), SOO mg/kg (RMSOO) or 1000 mglkg (RM1000) of 80% methanolic extract doses were used. Whereas the number of writhes was counted for 20 min just S min after intraperitonial injection of 0.6% acetic acid (O.lS mLilOg) for the writhing test, the reaction time of each mouse was evaluated at 30, 4S, 60, and 90 min after treatment for the hot-plate test. For the acute toxicity study, SOOO mglkg of aqueous or 80% methanolic extract was administered orally and observed for the following IS days. Both extracts displayed a clear dose-dependent diuretic and analgesic effect as compared to controls. RA1000 and RM7S0 were able to increase diuresis significantly (P
Assessment of Dot Implementation in Tigray, Northern Ethiopia
(Addis Ababa University, 2009-07) Alisani, Seid; Gedif, Teferi (PhD); Tadesse, Zerihun (PhD)
Mycobacterium tuberculosis infects one third of the world's population. Ethiopia ranks seventh in the world & third in Africa with TB prevalence. TB is the leading cause of morbidity, the third cause of hospital admission and the second cause of hospital death in Ethiopia. TB patients take drugs for very long period of time. Hence, adherence is a major problem. To resolve this issue, the World Health Organization recommends the strategy of Directly Observed Therapy-Short Course (DOTS) which includes Directly Observed Treatment (DOT) to ensure a better patient adherence. The observer may be a health worker or a trained and supervised community member. Studies elsewhere show varying results on the effectiveness of Community Based DOT (CBDOT) compared to Health Facility Based DOT (HBDOT) option. In Ethiopia, although attempts have been made to assess quality of DOT implementation, comparative effectiveness of CBDOT versus HBDOT programs has not yet been assessed. This study was conducted to assess effectiveness of DOT implementation in CBDOT and HBDOT program areas in Tigray region. The study also aimed to compare implementation practice between the two DOT options and identify the factors affecting DOT implementation. The study was a comparative cross sectional study conducted between October and December, 2008. Both quantitative and qualitative methods were used for data collection. The quantitative methods used were retrospective review of Unit TB Registers avai lable in the health faci lities, prospective observation of DOT observers' practice, exit interview of TB patients and selfadministered questionnaire for health profess ionals. The qualitative method used was Focus Group Discussions (FGD) for both groups. A total of 378 patients, 118 from Hintalo Wajirat (CBDOT) and 266 from Enderta (HBDOT) Woredas, registered from September 2005 to February 2008 treatment outcomes were reviewed retrospectively from Unit TB Registers. Effectiveness was measured by success rate. Treatment was successful for 101 (88.6%) and 181 (87.4%) new TB patients in CBDOT and HBDOT program areas, respectively. For new sputum smear positive pulmonary TB cases treatment was successful for 19 (90.5%) patients in CBDOT and 28 (84.8%) patients in HBDOT options. CBDOT option was as effective as HBDOT in treating TB patients and can achieve good treatment outcomes. CBDOT option also reduced transfer out of TB patients.This study found out that DOT implementation as indicated by observation of DOT provider practice was comparable for CBDOT and HBDOT program areas. This indicated that CBDOT observers can practice DOT like HBDOT providers. Hence, CBDOT can complement HBDOT and could be a viable alternative in areas where people live faraway from health facilities. The study also identified access, acceptability of DOT option and DOT providers, awareness of patients and providers, support to the patient, incentive to CBDOT providers, health improvement, documentation and supervision as factors that could affect DOT implementation. Voluntary Community Health Workers are available in each and every village and are willing to render service to their villagers. National/regional policy should be adopted to equip them with proper training and provide supportive supervision so that they tremendously increase both access and quality of DOT. Mechanisms should be devised to ensure that health workers develop supportive attitude and facilitate wide scale deployment of voluntary Community Health Workers. Key words: TB, DOT, CBDOT, HBDOT, Effectiveness, Treatment success and Tigray
Assessment of Hypertension Treatment Pattern At Selected Health Facilities in Addis Ababa and Consumption of Antihypertensive Drugs
(Addis Ababa University, 2009-10) Teshale, Mewael; Gedif, Teferi (PhD); Tesfaye, Fikru (PhD)
Background : Hypertens ion a long with other chronic diseases is on the rise in I~ thi opia. In fac t, the threats of non communicable diseases are not emerging rather they are well advanced and causing do uble burden to the society along with in fectious diseases. Unhealthy life sty le is the dcterminant for this dilemma. Needless to say, it needs time ly in tervention to tack le the problem. Despite or this fac t, studies on hypertension arc very few. This study assesses the treatment pattern to hypertension and consumption of antihypertensi ve drugs. Objective: To assess hypertension treatment pattern and consumption of anti hypertensive drugs. Methodology: An institution based cross sectional study involving retrospective data collection techniques (record review for the last five years and exit interview) was conducted between September and October 2008 . Results: The most commonl y prescribed drugs either alone or in combination were methyldopa, nifed ipine. hydrochlorothiazide. enalapril and atenolol. Treatment sh ift occurs freque ntly from thera peutic class to another on the basis of in effecti veness of the drug to adeq uate ly control blood pressu re, reason not known and side effect. Monoth erapy is favo red regard less of scx. Furosemide is the most consumed antihypertensive drug and nifedipine ranks the first with regards to cost of sales of antihypertensive drugs. Conclusion and recommendations: Methyldopa, ni fed ipine, hydrochlorothiazide, enalapri l and atenolol are widely used drugs for the treatment of hypertens ion whi ch is in accord with standa rd treatment guideli ne of the country. Future longitudinal research should be done to describc consumption trend of antihypertensive drugs.
Evaluation of the Anti Peptic Ulcer Activity of the Leaf Extract of Plantago Lanceolata in Rodents.
(Addis Ababa University, 2010-02) Melese, Endale; Engidawork, Ephrem
The lesion of peptic ulcer disease (PUD) is a disrflption in the mucosal layer of the stomach or duodenum. An ulcer is di stinguished from erosion by its penetration through the muscularis mucosa or the muscular coating of the gastric or duodenal wall. PUD results from the imbalance between defensive factors that protect the mucosa and offensive factors that disrupt this important barrier. There are several different types of modern drugs for the treatment of PUD though they are associated with clinically significant drug interactions, side effects, and relapse. Thus, there is a need to develop new drugs. for which natural products are potential candidates. Planlago lanceolala is used traditionally for the treatment of upper respiratory inflammation, urinary conditions. uterotonic. vascular disorders. wound, cough, ulcer etc. The present study was undertaken to evaluate the anti ulcer activity of the aqueous extract, and mucilage of P. lanceolala using different rodent models of PUD. Negative controls were given distilled water. Whilst positive controls received ranitidine in acetic acid induced chronic gastric ulcer, cysteamine Hel induced duodenal ulcer and pylorus ligation induced gastric ulcer models; misoprostol was used in indomethacin induced gastric ulcer. One group of animals received 200 mg/kg (for mice) and the other group received 400 mg/kg (for mice) of the aqueous extract in each model. In addition, one group of animals received 172 mg/kg of the mucilage in acetic acid induced chronic gastric ulcer model. The aqueous extract showed a better healing of ulcer than the mucilage in the acetic acid induced chronic gastric ulcer as evidenced by the higher percent reduction in ulcer index (77.9% vs 51.9%) and ulcer score Crable I). The aqueous extract was therefore, used for further evaluation. The effect of the aqueous extract at 400 mg/kg was more effective in healing and/ or protecting ulcer in virtually all models than 200 mg/kg. The extract at both 200 mg/kg and 400 mg/kg produced reduction in ulcer index (P<0.05 and P
Quality Evaluation of Clobetasol Propionate and Betamethasone Valerate Topical Corticosteroid Creams Marketed in Addis Ababa
(Addis Ababa University, 2010-04) Terefe, Abebayehu; Gebre-Mariam, Tsige(Professor)
Topical corticosteroids have revolutionized the practice of dermatology since their introduction in the late 1950s. They have improved the management of many inflammatory skin diseases but like all medications, the drugs are associated with potential adverse (side) effects. Five brands of cream formulations (GlaxoSmithKline of England and Saudi Arabia), Zygpharma pvt. Ltd (India), Hoe Pharmaceuticals (Malaysia) and Pharma Inkl (Jordan)) containing, 0.05 % w/w clobetasol -17-propionate (CP) and 0.1% w/w betamethasone -17-valerate (BV) as active ingredients were purchased from different retail outlets in Addis Ababa and their qualities were evaluated for microbiological, identification (qualitative) and assay(quantitative) tests using the official USP 2008. Microbial limit test mannital – salt and cetrimide agar media were used to test the presence or absence of Staphylococcus aureus and Pseudomonas aeruginosa, respectively. The specimens were incubated for five days at a temperature of 25 OC but the growth of the expected microorganisms were not observed ( i.e the results were negative ). Identification test was performed using thin layer chromatography; clobetasol propionate (1.0 gm) and betamethasone valerate (2.0 gm) creams were weighed and extracted with a series of steps using appropriate chemicals which are recommended by USP 2008. The dried residues were dissolved in chloroform and equal volumes (10μl) of the standards and the tests were spotted. After the plates were dried in the hood their retention factor (Rf) values were calculated by measuring the distance traveled by the standards and the extracts to that of the solvent front and found to be as 0.56 for clobetasol propionate and 0.33 for betamethasone valerate. x Assay was performed by using RP-HPLC. Clobetasol propionate (2 gm) and betamethasone valerate (2.5 gm) cream were weighed and extracted with methanol. The mixtures were shaken using a shaker and centrifuged at about 3500 rpm for 10 minutes followed by filtration through a 0.45 μm filter paper and the filtrates were added into a vial. Equal volumes of the standard and the sample (10 μl) were injected at a flow rate of 1.0 ml/min for clobetasol propionate and 1.2 ml/min for betamethasone valerate and the amount in mg of each active ingredient were found as 0.908 to 1.149 mg (90.8-114.9%) clobetasol propionate and 2.41 to 2.76 mg (96.4-110.4 %) betamethasone valerate. The above results showed that all the brands of the two cream products fulfill the USP 2008 specifications interms of physical stability (appearance), microbiological, identification and assay tests. Key words: corticosteroids, clobetasol 17-propionate, betamethasone-17-valerate, microbial limit, identification, assay and retention factor.
Preparation and Characterization of Pregelatinized Enset Starch and Evaluation of its Use as Binder and Disintegrant in Tablet Formulations
(Addis Ababa University, 2010-05) Wondimu, Abrham; Gebre-Mariam, Tsige(Professor)
Ensete ventricosum (Welw.) Cheeseman which belongs to the family Musaceae is a potential source of starch in Ethiopia. Starch is usually modified either chemically or physically to augment its convenience for industrial use. In this study, enset starch was modified by a physical method called pregelatinization. Properties of pregelatinized enset starch such as, densities, flow, swelling power, percentage solubility, moisture sorption, and compactability were investigated and compared to those of native enset starch and Starch 1500®. The comparative binding and disintegrant abilities of these starches in tablet formulations were also studied using paracetamol as a model drug. The granules prepared with the starches at different binder concentrations were characterized for particle size distribution, friability, and flow properties and the tablets were tested for crushing strength, friability, disintegration time, and dissolution rate using standard methods. The results indicated that pregelatinization improved the flowability of enset starch. Generally, the swelling power and percent solubility of the starches were found to increase with temperature and the values are higher for pregelatinized starches. The moisture sorption profiles indicate that the relative humidity during tablet production and storage should be carefully controlled. The compaction study revealed that the tensile strength of the compact of pregelatinized enset starch (10.14 Kg/cm2) and Starch 1500® (12.24 Kg/cm2) were comparable (p > 0.05). Compacts from native enset starch, however, presented significantly lower tensile strength (5.60 Kg/cm2). The results also indicate that granules and the tablets prepared with pregelatinized enset starch and Starch 1500® exhibit comparable characteristics. An increase in binder concentration provided tablets with increased crushing strength and disintegration time and decreased friability. The study also revealed that the softening of the tablets prepared with native starch as a disintegrant was reduced when prepared with pregelatinized starch. The dissolution studies of the paracetamol tablets showed that the release of the drug was within acceptable range (quantity dissolved in 30 min ≥ 80%). Thus, it can be concluded that pregelatinized enset starch can be a better binder and disintegrant than the native one in tablet formulations. Key Words: Enset Starch; Pregelatinized Starch; Tablet; Binder; Disintegrant.
Physico-Chemical Characterization and Evaluation of Two Local Cactus Mucilages (Opuntia Spp.) as Suspending Agents
(Addis Ababa University, 2010-05) G/Samuel, Naod; Gebre-Mariam, Tsige (Professor)
Ethiopia is one of the countries where cactus grows naturally. Cactus pear (Opuntia spp.), Cactaceae family, is a plant with an impressive genetic diversity of over 400 species. Cactaceae are well adapted to arid and hot drylands, where the plants have a marked capacity to withstand prolonged drought. The peculiar feature of the plant to adapt such areas is because of the presence of mucilage in specialized cells of the cladodes. Mucilage is a complex carbohydrate with a highly branched structure, which contains varying proportions of L-arabinose, Dgalactose, L-rhamnose and D-xylose, as well as galacturonic acid in different proportions. It swells in water and form viscous mass. Hence, recently an attention is being paid for its potential use in industry: food, cosmetic and pharmaceutical sectors. The objective of this study is to determine the physico-chemical properties of mucilages of Opuntia ficus-indica and Opuntia stricta, the two most abundant cactus species in Ethiopia, and evaluate their suspending ability in pharmaceutical suspensions. The physico-chemical properties of the mucilages were compared between themselves. The suspending abilities of the mucilages were compared with NaCMC. The dissolutions of the suspensions were performed using the USP paddle method at 25 rpm. The yield of mucilage from both Opuntia spp. was found to be comparable. The solubility and SP of the mucilages were also studied. With increase in temperature the solubility increased and was comparable in both mucilages. However, at all the treatment levels the SP were higher in mucilage of OS than that of OFI the differences of which were statistically significant. At 100% RH the moisture sorption property of OFI and OS were 95.4% and 76.9%, respectively. The pH values of both mucilages were found to decrease upon increasing mucilage concentration which at 12% (w/v) dispersions were 5.57 and 5.87 for OFI and OS, respectively. The results showed that these pH values are to be classified within low acid group. The conductivity, at 12% (w/v), of OFI was found to be 13.12 mS/cm while that of OS was 9.31 mS/cm. The apparent viscosities at 12% (w/v) were 9,017 mPas and 10,060 mPas for OFI and OS, respectively. The apparent x viscosities of the dispersions decreased with increase in shear rates which rendered the dispersions a pseudoplastic flow. These physico-chemical properties of the mucilages can signal on their potential use in pharmaceutical formulations especially suspensions. Hence, Paracetamol suspensions using the mucilages and NaCMC as suspending agents were formulated. The apparent viscosities of the suspensions in all the suspending agents concentration levels and applied shear rates were in the order of NaCMC>OS>OFI with non-Newtonian flow and accordingly the flow rates of the suspensions were in the order of OFI>OS>NaCMC. The sedimentation volumes (%) of the suspensions in all the suspending agent concentration levels were higher for OS followed by OFI and then NaCMC. The high sedimentation volumes (%) of suspensions, in turn, were accompanied by ease of redispersibility of that order. The effect of electrolyte on sedimentation volume (%) had dual effect. It was only the suspensions that had NaCMC that showed increase in sedimentation volume (%) in all molar NaCl concentration. However, in suspensions that had mucilages of OS and OFI, an initial increase in sediment volumes (%) were accompanied by decrease after 1x10-3M and 1x10-2M of NaCl, respectively. Moreover, the effect of pH on sedimentation volume (%) was addressed. Hence, the suspensions from NaCMC were stable in acidic media while suspensions from OFI and OS were stable in basic media. Dissolution of the suspensions which had mucilages attained the acceptable ranges (≥ 80% drug release in 30 min) in 5 min. Similarly, except A6 formulations A2, A3, A4 and A5 have attained the limit but the release was not as quick as the previous formulations. Hence, it can be concluded that mucilages of Opuntia spp. (Opuntia ficus-indica and Opuntia stricta) can be used as alternatives to NaCMC as suspending agent in suspension formulations. Key words: Cactus, Mucilage, Opuntia spp., Sedimentation volume, Suspension, Suspending agent
Formulation and Evaluation of Solid Dispersion Capsules Containing Erythromycin Stearate
(Addis Ababa University, 2012) Mukesh, Shweta; Feleke, Fitsum(PhD); Mary, Nisha(PhD)
Erythromycin stearate is a macrolide and belong to one of the most commonly used families of clinically important antibiotics used to treat infections caused by Gram-positive bacteria such as Staphylococcus aureus, Streptococcus pneumonia and Streptococcus pyogenes. The objective of this study was to increase the solubility of the poorly water soluble drug erythromycin stearate, by the formation of solid dispersion. Solubility is an important physicochemical factor affecting absorption of drug and its therapeutic effectiveness. In the present investigation, an attempt was made to improve the solubility and dissolution rate of a poorly soluble drug, Erythromycin stearate. The dispersion carriers used for the study were PEG4000, PEG 6000 and PVP K30. Fusion method, Solvent Evaporation method and Kneading methods in 2:1, 1:1 and 1:2 ratios of drug to polymer were used to prepare the solid dispersion. The formulation were characterized for drug-polymer interaction using FTIR spectrum and DSC, solubility parameters, drug content studies, drug release studies. The interaction studies showed no interaction between the drug and the polymers. Formulations containing 1:2 ratio of drug: PEG4000, drug:PEG6000 prepared by fusion method showed the best release with a cumulative release of 97.55% and 101.78% respectively as compared to 54.62% for the pure drug. The flow property studies like angle of repose , hausner's ratio and carr's index showed the solid dispersion preparation had good flow. The practical yield was found to be above 90% for all the formulations. Similarly the drug content was also above 90% for all the formulation except, the solid dispersion prepared by kneading method. The XRD studies showed the crystallinity of the solid dispersion reduced compared to the drug alone. Drug to PVPK30 1:2 ratio prepared by solvent evaporation method showed cumulative release of 96.31%. The results of short term stability studies showed good stability within the studied period of 3 months at the temperature 40C and relative humidity of 75%.
Preparation and Evaluation of Dual Modified Ethiopian Yam (Dioscorea abyssinica) Starch for Sustained Release Tablet Formulation
(Addis Ababa University, 2013-01) Mulualem, Yohaness; Gebre-Mariam, Tsige (Professor); Belete, Anteneh(PhD)
Starch has been the subject of intensive research over many decades due to the fact that native starches are diverse, biodegradable, applications are enormous and modifications to starch are numerous. In this study, Dioscorea abyssinica (boyna) starch has been chemically modified with the aim of determining its potential for sustained release application. It was chemically modified by cross-linking using sodium hexametaphosphate (SHMP), acetylating with acetic anhydride and dual modified - cross-linking followed by acetylation. Cross-linked starches (CLSs) with degree of cross-linking (DC) of 54.46, 62.20 and 68.88 (%), CLS-A, CLS-B, CLS-C respectively, were obtained while cross-linking the native starch (NS) with 5, 10, and 15% SHMP for 6 h. By reacting boyna starch with acetic anhydride (AA) in ratios of 1:1 and 1:2, starch acetates (SAs) with degrees of substitution of 0.339 (SA-A) and 0.546 (SA-B), were obtained, respectively. In an attempt to prepare a dual modified starch (DMS), the CLSs were acetylated in a similar condition as the NS. The physicochemical, material, and tablet forming properties of the modified starches were investigated to determine potential usages in sustained release applications. In moisture sorption study, CLSs exhibited the lowest water-uptake and SAs notably increased the sorption capacity of the NS and CLS. Cross-linking decreased the swelling power of the NS as the level of SHMP was increased while acetylation showed the opposite effect. The reduction observed in viscosity values indicated the effectiveness of cross-linking in reducing swelling of the NS. On the basis of powder properties analyses, it was evident that acetylation improved the poor flow properties of CLSs and NS. SAs were found to be free flowing with angles of repose of 25.11O and 23.02O and flow rate of 3.09 and 10.54 g/sec, respectively for SA-A and SA-B. The Hausner ratio of the SAs was 1.18 and 1.25 and Carr’s index of 22.36 and 20.24, respectively for SA-A and SA-B. Tablets were prepared and evaluated for hardness, tensile strength, friability, and disintegration time. Results indicated that both cross-linking and acetylation processes improved tablet forming properties of the NS with more significant effect in the dual modified starches. The Fourier transform infrared (FTIR) spectra revealed that a structural change occurred in the NS because of cross-linking and acetylation. Correspondingly, the spectral analysis proved that the dual modified starches are compatible with theophylline. iv Dissolution studies of theophylline loaded modified starches were performed for 12 h. Matrix tablets containing Ac-CLS-F, where CLS-C reacted in a 1:2 ratio with AA, loaded with 20, 30 and 40% theophylline and Ac-CLS-E, where CLS-C reacted in a 1:1 ratio with AA, loaded with 20% theophylline were studied for drug release. And 80% of theophylline was released in about 10.62, 9.35, and 8.18 h from 20, 30 and 40% theophylline loaded Ac-CLS-F, respectively, whereas 20% theophylline loaded Ac-CLS-E released its drug content within about 12 h of the dissolution study. The dissolution data was subjected to the various drug release kinetic models and the data best fitted Higuchi model with R2 > 0.994. The drug release diffusional exponent (n), with goodness of fit > 0.988 obtained for Korsemeyer-Peppas model for 20, 30 and 40% drug loaded Ac-CLS-F varied between 0.452-0.530 indicating deviation from Fickian diffusion mechanism whereas a quasi-Fickian diffusion behavior was exhibited (n = 0.31) for 20% loaded Ac-CLS-E. From the foregoing, it can be concluded that Ac-CLS-F could have a potential for use as a sustained release excipient. Key words: Dioscorea abyssinica, Boyna starch, Cross-linking, Acetylation, Dual modification, Sustained release.
Assessment of complications of anticoagulant therapy at medical wards of Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia
(Addis Ababa University, 2014-01) Gebrehiwot, Teklu; Shibeshi, Workineh(PhD); Gebremedhin, Amha(PhD)
Anticoagulant therapy is one of the most common form of medical treatment. The most common anticoagulant therapy complications are bleeding and thromboembolic complications. Bleeding is the primary complication. Factors that can affect the complications include age, gender, comorbidities, intensity of anticoagulant effect, length of therapy and concomitant drugs. The objective of the study was to assess complications of anticoagulant therapy at medical wards of Tikur Anbessa Specialized Hospital. A prospective longitudinal study design involving patient follow-up and chart review was conducted from November to June 2014. Chi-square test and Linear Mixed Model regression were employed to examine the relationships and associations between variables. The incidence of complications of anticoagulant therapy was found to be 60 (26%). Bleeding was the most common reported 27 (12.4%) (5.2% major, 10.7% minor), followed by thromboembolism 12 (7.1%), bruising 10 (5.9%), heparin induced thrombocytopenia 9 (5.3%) and skin necrosis 8 (4.7%). Sex, concomitant drugs, intensity of INR/aPTT values, usual trend of coagulation treatment and having coagulation profiles from different laboratory sites had been associated with complications. However, age, comorbidities, length of therapy, number of anticoagulants and anticoagulant therapy related factors were not significant risk factors. The findings of this study indicated that patient on anticoagulant therapy at medical wards were at higher risk of bleeding followed by thromboembolic complications. Availability of coagulation laboratory reagents at Tikur Anbessa Specialized Hospital and preparing guidelines on anticoagulant therapy harmonized with the laboratory values is recommended. Key words: Complication, bleeding, thromboembolism, skin necrosis, bruising, HIT, INR, aPTT, anticoagulants
Assessment of Utilization Pattern of Topical Steroids in Alert Hospital
(Addis Ababa University, 2014-04) Negussie, Hanna; Gedif, Teferi (PhD)
Topical steroids comprise the mainstay treatment of skin diseases. However, irrational prescription of topical steroids is a common occurrence in clinical practice and they are being abused by health professionals and patients alike. This study was performed to assess the utilization pattern of topical steroids in ALERT Hospital, Addis Ababa. The study employed a descriptive, cross sectional study design, using both quantitative and qualitative methods between August and November, 2013. Data abstraction format was used to collect the data from a total of 660 patient records and an interview guide was employed to collect data qualitatively. The quantitative data was analyzed using SPSS version 16 and the qualitative data was analyzed thematically. The majority of patients were females 380(60.9%) and their mean age was 24.2 years. Eczematous dermatitis 211(30.0%) was the single most common skin diseases observed. However, infectious skin diseases were the most common skin dermatoses 230(33.8%) when combined. The most commonly prescribed classes of drugs were topical steroids and its combination 315(28.4%) followed by anti-fungal drugs 245(22.1%). There were a total of 1108 drugs prescribed, with an average of 1.77 drugs per prescription. Topical steroids and its combination were found to be the most commonly prescribed drugs. A total of 315 topical steroids were prescribed and brand name was used in 307(97.5%) of them. The most commonly prescribed topical corticosteroids were betamethasone dipropionate 77(24.4%) and clobetasol propionate 73(23.2%), which are potent and very potent topical corticosteroids, respectively. Out of all the topical corticosteroids prescribed, the majority were potent 174(55.2%) and very potent 73(23.2%). Prescribers‘ adherence is to the ALERT Medicines Formulary and National Standard Treatment Guideline was found to be 100% and 58.1%, respectively. In most prescriptions, site of application, duration of treatment and quantity to be dispensed was inadequate; a practice that should be improved. Key words: Prescription pattern, Topical steroids/corticosteroids, Skin diseases

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