Trends and Challenges in Access to Essential Medicines in Ethiopia and the Contributions of Local Pharmaceutical Production

Decades ago, the United Nations declared that access to essential medicines was a key element of universal human rights. Accordingly, member  states have been striving to address this issue through strategic policies and programs. Strengthening local pharmaceutical production has been a  pivotal strategy adopted by many developing countries including Ethiopia. The government of Ethiopia identified local pharmaceutical production  as a key industrial sector and has been implementing a ten-years strategic plan to improve capabilities and attract investment. Such support is  needed because local production could satisfy only 15 to 20% of the national demand, typically from a limited portfolio of medicines in conventional  dosage forms.The increasing prevalence of chronic diseases has accentuated the need for a more sustainable supply to reduce reliance on imports  and increase access to essential medicines. A full understanding of the structure, constraints and complexities of the Ethiopian pharmaceutical  market structure is vital to direct effective policies, target most impactful investments and exploit opportunities for leapfrogging. Hence, the  purpose of this review was to assess the trends and challenges in access to essential medicines and local pharmaceutical production in Ethiopia.  Literature search through major databases and review of policy documents and performance reports from relevant sector institutions were made to  extract information for the review. &nbsp

Magnitude and associated factors of virological failure among children on ART in Bahir Dar Town public health facilities, Northwest Ethiopia: a facility based cross-sectional study

Background Despite the rapid scale-up of antiretroviral therapy, virologic failure has become global public health concern and challenge, especially in developing countries. Viral load monitoring is an important approach to identify treatment failure and develop public health interventions in children receiving antiretroviral therapy. Thus, this study aims to assess the magnitude and associated factors of virological failure among children on antiretroviral therapy. Methods A facility-based cross-sectional study was conducted among 399 HIV-positive children on antiretroviral therapy from 2016 to 2019 in Bahir Dar Town public health facilities. Data were extracted from children’s charts using a standardized data extraction tool, adapted from ART intake and follow-up forms. Data were entered using Epi-Data Version 3.1, and analyzed using SPSS Version 25. Bivariable and multivariable binary logistic regression models were done to identify factors associated with virological failure. Variables with p-values < 0.25 were fitted into the multivariable analysis. Finally, variables with p-values <0.05 were considered as statistically significant factors. Results The period prevalence of virological failure was found to be 14.8% (95% CI: 11.5–19.3%). Opportunistic infections (AOR = 2.19, CI: 1.13–4.25), history of treatment interruption and restart (AOR = 2.21, CI: 1.09–4.54), younger age (AOR = 2.42, CI: 1.02–5.74), poor/fair ART adherence (AOR = 2.19, CI: 1.05–4.57), and advanced baseline WHO clinical staging (AOR = 2.32, CI: 1.14–4.74) were found to be factors significantly associated with virological failure. Conclusion The magnitude of virological failure among HIV-infected children remained high. Children with poor/fair ART adherence, history of treatment interruption, advanced baseline WHO clinical staging, younger age, and opportunistic infections were significantly associated with virologic failure. Thus, special attention should be given to children who had poor/fair ART adherence and presenting with opportunistic infections

COMPARATIVE IN VITRO EVALUATION OF BRANDS OF CLOTRIMAZOLE CREAM FORMULATIONS MARKETED IN ETHIOPIA

The aim of present work was to undertake comparative in vitro quality evaluation of six marketed clotrimazole cream formulations in Ethiopia with respect to physico-chemical properties like viscosity, spreadability, extrudability, pH and drug content. In vitro clotrimazole release from cream formulations was also studied using synthetic cellulose acetate membrane at 37 ºC in a solvent containing methanol and PBS 7.4 in the ratio of 75:25 as receiver medium. The cumulative amounts of the drug released over 12 h (µg mm-2) were analyzed. All clotrimazole cream formulations showed good and smooth homogeneous appearance with white color. The pH of clotrimazole cream formulations ranged from 4-7, which is a physiologically acceptable pH range and in principle devoid of any skin irritation. Clotrimazole content ranged from 90-110%, ensuring the uniformity of the drug content in all formulations. The increase in diameter of clotrimazole cream formulations following the spreadability test was found to range from 4-6 cm. Cream formulation D (Clotri-Denk) exhibited highest viscosity values than other formulations, whereas formulation E (Chinese Clotrimazole BP) showed lowest viscosity value. Cream formulation F (Mycoril) showed better extrudability and spreadability as compared to other formulations. Drug release from all formulations was slow in the first 6 hrs. After the 6th hr, steady drug release continued for formulation D and E. Fast drug release was observed in formulations A (Candid) and B (Candigen), whereas for the formulations C (Canesten), D and E, steady drug release pattern was observed after the 6th hr. It can be concluded that all clotrimazole cream formulations fulfilled the quality criteria of in-house and pharmacopeias specifications. Keywords: In Vitro Evaluation, Clotrimazole, Cream, Spreadability, Extrudability, Ethiopi

COMPARATIVE IN VITRO EVALUATION OF DIFFERENT BRANDS OF NIFEDIPINE 20mg RETARD TABLET PRODUCTS MARKETED IN ADDIS ABABA, ETHIOPIA

Nifedipine has been formulated and marketed as extended-release-film coated tablet. A certain degree of success has been achieved in reducing the incidence of adverse effects by the use of slow-release formulations such as nifedipine retard. The aim of the present study was to evaluate the physicochemical quality attributes and in vitro equivalence of six brands of nifedipine retard tablets available in different retail outlets in Addis Ababa, Ethiopia. After constructing the calibration curve, the in vitro drug release studies were carried out using USP type I dissolution apparatus at 100 rpm. The dissolution was done in a medium of 0.1N HCl containing 0.5% sodium lauryl sulfate for 12 hrs. All the tablets met the requirement for tablet weight uniformity. The mean crushing strengths of sample tablets ranged from 49.2 to 111.2 N. All the brands  studied released more than 80% within 12 hours which is within the tolerance limit.  However the release profile revealed that five of the brands showed over 15% drug release at 1st hour except product F which released only 14.32%. In conclusion, all the brands of tablets had uniform thickness and good hardness. Despite all the brands could sustained the release for over 12 hours recommended for such formulations, five of them showed higher release in the first hour which may affect their in vivo performance.†Keywords: nifedipine, retard tablets, physicochemical properties, crushing strengths, in vitro drug releas

Evaluation of Opuntia stricta mucilage as sustained release excipient in diclofenac sodium matrix tablet formulations

Over the last few decades, plant derived polymers have received increasing attention due to their diverse pharmaceutical applications including modified and controlled drug delivery. Among these natural polymers, mucilages and gums are versatile excipients for pharmaceutical formulation. The main objective of the present study was to evaluate cactus (Opuntia stricta) mucilage as a matrix forming polymer for sustained release tablet formulations using diclofenac sodium as a model drug. The mucilage from cactus cladode was extracted using distilled water as extracting solvent and ethanol as mucilage precipitant. The mucilage powder was characterized for its physical properties. A 1% w/v solution of the mucilage in water gave a pH of 6.40 ensuring low irritability potential when used in uncoated tablets. Evaluation of the powder flow profile demonstrated fair flow showing the need for incorporating other compressible excipients or using granulation to enhance the flow pattern. The solubility and swelling power of the O. stricta were generally low at low temperature (20 ºC), but increased significantly at higher temperature (85 ºC) (p &lt; 0.05). The percentage moisture sorption ranged from 7.61% at 15% to 79.9% at 100% relative humidity (RH). The granules prepared with water as granulating solvent showed excellent flow property. The crushing strength of wet granulated formulations was higher than directly compressed formulations. The in vitro dissolution study demonstrated that both directly compressed and wet granulated formulations of O. stricta mucilage effectively sustained diclofenac release for over 12 h even at a lower concentration of 10%. However, granulation showed a better matrix performance for sustaining the drug release. All the formulations showed good linearity with respect to Korsmeyer-Peppas equation with 0.45 ≤ n ≤ 0.89 indicating that, non Fickian diffusion was the predominant mechanism of drug release from these formulations. So, O. stricta mucilage can be used as alternative pharmaceutical excipient in the formulation and manufacture of sustained release matrix tablets.Keywords: Opuntia stricta mucilage, direct compression, in vitro drug release, wet granulation, matrix tablet