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Formulation Development of Generic Omeprazole 20 mg Enteric Coated Tablets

Pharmacology & Pharmacy 2015年第7期6卷 293-301页

作者： Christopher Oswald Migoha eliangiringa kaale Godliver Kagashe Tanzania Food and Drugs Authority Dar es Salaam Tanzania Pharm R&D Lab School of Pharmacy Muhimbili University of Health and Allied Sciences Dar es Salaam Tanzania Department of Pharmaceutics School of Pharmacy Muhimbili University of Health and Allied Sciences Dar es Salaam Tanzania

Omeprazole is a potent proton pump inhibitor with powerful inhibition of secretion of gastric juice. Oral site-specific drug delivery systems have recently attracted a great interest for the local treatment of bowel disease and for improving systemic absorption of drugs which are unstable in the stomach. However, microenvironment in the gastrointestinal tract and varying absorption mechanisms cause hindrance for the formulation and optimization of oral drug delivery. The objective of the study was to develop and optimize enteric coating process for omeprazole tablets. Different batches of core tablets were sub coated, one set sub coated with opadry and another with a mixture of light magnesium oxide, magnesium stearate and absolute alcohol omeprazole magnesium. Seal coating was applied by using opadry to achieve certain weight gain and to protect omeprazole from acidic coating polymers. A comparative dissolution test was performed. The variation of thickness and diameter were observed to be minimal with a weight gain of 3% - 4% of enteric polymer. Disintegration test showed that in each tested batch the enteric coated layer remained intact in 0.1N HCl for 2 hours and when exposed to alkaline media of phosphate buffer pH 6.8, it dissolved within few minutes. Dissolution release was 98.8% to 102.4% within two hours when the product was exposed to phosphate buffer pH 6.8 after 2 hours. The similarity and dis-similarity factors were calculated and observed to be 54 to 61 and 4 to 5 respectively. Therefore a simple and good enteric coating process was developed and tested with potential for transfer this technology into local pharmaceutical industries using cheap and easily available materials.

关键词： Omeprazole Magnesium Enteric Coating Tablets Kollicoat (Methacrylic Acid/Ethyl Acrylate Copolymers) (MAE)

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Development of a Qualitative near Infrared Screening Method for Quality Consistency Assessment of Virgin Sunflower Oil

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Spectral Analysis Review 2017年第3期5卷 25-36页

作者： Fredrick Luyangi eliangiringa kaale Vicky Manyanga Veronica Mugoyela Tanzania Food and Drugs Authority Dodoma Tanzania Department of Medicinal Chemistry Muhimbili University of Health and Allied Sciences (MUHAS) Dar es Salaam Tanzania Pharm R&D Lab School of Pharmacy Muhimbili University of Health and Allied Sciences (MUHAS) Dar es Salaam Tanzania

Near infrared spectroscopy offers advantages in the analysis of vegetable oils such as rapidity, relative cost-effectiveness, and usually no need for sample preparation. Virgin Sunflower oils were used as reference standards to develop spectra library for qualitative identification and validation of the method. This model was validated by correct classification method using positive and negative control samples. Various market samples of virgin sunflower oil were purchased and compared with spectra library. The results of spectral analysis of reference library and market samples were correlated using Mahalanobis distance method. Analysis involved 22 market samples. When these samples were matched against calibration samples, 4 samples out of 22 which are about 18.2% were not matched by the reference model. These market samples had Mahalanobis distance values between 4.2 and 6.7, which are greater than maximum permissible value of 3. Some of adulterants mentioned were Korie oil and pumpkin seeds oil.

关键词： Mahalanobis Distance Near Infrared Mean Center Correction and Virgin Sunflower Oil

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Assessment of Medicines Cold Chain Storage Conformity with the World Health Organization Requirements in Health Facilities in Tanzania

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Pharmacology & Pharmacy 2017年第10期8卷 325-338页

作者： Siya Ringo Veronica Mugoyela eliangiringa kaale Joseph Sempombe Dar es Salaam City Council Dar es Salaam Tanzania Department of Medicinal Chemistry Muhimbili University of Health and Allied Sciences (MUHAS) Dar es Salaam Tanzania Pharm R&D Lab School of Pharmacy Muhimbili University of Health and Allied Sciences (MUHAS) Dar es Salaam Tanzania

A descriptive study on assessment of medicines cold chain storage conformity with World Health Organization (WHO) requirements in public health facilities was carried out in Dar es Salaam and Dodoma regions. Storage conformity in selected health facilities was assessed by monitoring temperature using temperature data loggers mounted in the refrigerators for a period of 30 days. Results indicated almost half of the health facilities 48.5% visited, did not significantly (P = 0.031) comply with storage temperature (+2°C to +8°C) as per WHO requirement because all recorded Mean Kinetic temperature (MKT) > 8°C. In rural areas, 59.2% of visited health facilities adhered to the WHO recommended storage temperature while in urban areas only 31.6% complied. The study has established electricity failure in urban and lack of gas in rural areas coupled with absence of contingency plan as major challenges to WHO temperature conformity in storage of cold chain medicines in health facilities in Tanzania.

关键词： Temperature Monitoring Cold Chain Medicines Mean Kinetic Temperature World Health Organization Standards

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Pre-Formulation Development of Lamivudine 300 mg and Tenofovir Disoproxil Fumarate (TDF) 300 mg Fixed Dose Combination Tablets

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Pharmacology & Pharmacy 2016年第7期7卷 247-254页

作者： Prosper Tibalinda Dickson Pius Raphael Shedafa Nelson Masota Mary Temu eliangiringa kaale Pharm R&D Laboratory School of Pharmacy Muhimbili University of Health and Allied Sciences (MUHAS) Dar es Salaam Tanzania Department of Pharmaceutics and Pharmacy Practice Muhimbili University of Health and Allied Sciences (MUHAS) Dar es Salaam Tanzania Medicinal Chemistry Department Muhimbili University of Health and Allied Sciences (MUHAS) Dar es Salaam Tanzania

Introduction: In this study, physical and chemical characteristics of Lamivudine, Tenofovir Disoproxil Fumarate (TDF) and potential excipients were systematically followed and documented [1]. Objective: The objective of this scientific work was to carry out pre-formulation studies including compatibility studies on Lamivudine and Tenofovir Disoproxil Fumarate with their potential excipients prior a direct compression process [2]. Methodology: The interaction was studied in three set of environments namely uncontrolled room conditions for Zone VI b (30°C ± 2°C), oven conditions in which the oven was set at 50°C and accelerated climatic conditions in which a climatic chamber was set at 40°C ± 2°C/75% ± 5% Relative Humidity (RH %). Sample preparation was done by mixing the amount of formulation excipients to active substances at a ratio of 1:10, whereas active substance to another active substance at a ratio of 1:1, active substance to coating materials at 1:4, coating materials to the whole set of excipients 1:4. The whole set of samples was geometrically mixed and triturated by mortar and pestle to very fine uniform powder to ensure homogeneity of the mixture. HPLC analytical method was used for simultaneous quantitative determination of lamivudine and tenofovir disoproxil fumarate. Transmittance of the mixture was determined by Near Infra-Red (NIR) technique. Results: The amount of Lamivudine as on day 0 was comparable to day 90 for in all tested conditions (Room, Oven and Climatic Chamber), whereas for Tenofovir Disoproxil Fumarate only the amount of the drug at Room (30°C ± 2°C) was comparable to results on day 90. A significant drop of amount of Tenofovir Disoproxil Fumarate (TDF) exposed to moisture (Climatic chamber at 40°C ± 2°C/75% ± 5% Relative Humidity (RH %)) and temperature of 50°C was observed. Colour change was observed for samples subjected to moisture (Climatic chamber at 40°C ± 2°C/75% ± 5% Relative Humidity (RH %)) and as well picked up in the NIR r

关键词： Compatibility Interaction Pre-Formulation Lamivudine and Tenofovir Disoproxil Fumarate

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Assessment of Moisture Permeability and Closure Systems of High Density Polyethylene Plastic Bottles Used as Primary Packaging Containers for Moisture Sensitive Medicines

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Pharmacology & Pharmacy 2016年第8期7卷 321-325页

作者： Raphael Shedafa Prosper Tibalinda Vicky Manyanga Joseph Sempombe Marry Temu Nelson Masota eliangiringa kaale Christoph Bonsmann Medicinal Chemistry Department Muhimbili University of Health and Allied Sciences (MUHAS) Dar-es-Salaam Tanzania Pharm R&D Laboratory School of Pharmacy Muhimbili University of Health and Allied Sciences (MUHAS) Dar-es-Salaam Tanzania Department of Pharmaceutics and Pharmacy Practice Muhimbili University of Health and Allied Sciences (MUHAS) Dar-es-Salaam Tanzania German Medical Aid Organization Tonisvorst Germany

Introduction: Moisture permeability and a loose closure system might allow a significant gain of moisture into container and this could lead to significant loss of potency of drug sensitive to moisture and as well promoting the growth of microorganisms. Typical examples of the drugs sensitive to moisture include Tenofovir Disoproxil Fumarate (TDF). Product claimed to be a “Tight container” does not make it a tight container until proved practically. A plastic container is tight if “not more than one of the 10 tested containers exceeds 100 mg per day per L in moisture permeability. Objectives: The goal of this study was to determine rate of moisture permeability of selected High Density Polyethylene plastic bottles for packaging of moisture sensitive medicines in particular Lamivudine/Tenofovir Disoproxil fumarate tablets. Methodology: The determination of rate of moisture permeability was achieved by assessing closure systems of plastics as per USP 37 method, while the difference in absorption pattern was achieved by assessing the spectrum obtained through transmittance by Fourier Transform-Infrared (FT-IR). The plastic bottles were randomly selected from supplier A, B and C. Results: The plastic bottles from supplier A and B had an average moisture permeability of 12.57 and 51.55 mg/day/L with none of the containers exceeding moisture permeability of 100 mg/day/L whereas containers from supplier C had an average of 149.95 mg/day/L with seven of the containers exceeding of 100 mg/day/L. Conclusion: Containers from supplier A and B met the USP specifications hence could be used as primary packaging for moisture sensitive medicines whereas the containers from supplier C did not meet the USP specifications for them to be regarded as “Tight Containers” and hence, unsuitable for packaging of moisture sensitive medicines.

关键词： Moisture Permeability Closure System Primary Packaging Containers

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