The usage of fixed dose combination (FDC) tablets of Lamivudine and Tenofovir Disoproxil Fumarate (TDF) is increasing due to increased incidences of HIV/Hepatitis B and HIV/TB co-infections. This is likely to increase the financial crisis due to limited resources for funding procurement of ready-made products from the pharmaceuticals manufacturing leading countries. Therefore, production of local oral tablets containing Lamivudine and TDF FDC is inevitable. Lamivudine 300 mg/TDF 300 mg tablets were developed and optimized by D-optimal mixture design and produced by direct compression technique. Twenty trial formulations with independent variables, including PVP-CL 1–12.00%, PVP-K30 1–10.00%, starch-1500 2.5–12.5% and Avicel-PH102 2–19.25% were prepared by direct compression technique. The formulations were assessed on assay, dissolution, friability, weight variation and disintegration time. It was found that assay ranged from 98.13–101.95% for Lamivudine, 98.25–102.84 for TDF, both were within the in-house assay specification of 95 to 105%. Dissolution at single point was above 80% for Lamivudine 93.96–100.55% and 95.85–103.15% for TDF, disintegration time was between 1.92–66.33 min and friability 0.06–12.56%. Out of twenty formulation trials, eight formulations had all parameters in proven acceptable range. On optimization, one formulation with independent variables, PVP-CL 5.67%, PVP-K30 1.00%, Starch-1500 5.76% was selected. The optimized formulation was comparable to the reference product on the market with similarity factor (f2) and difference factor (f1) within the acceptable range for both Lamivudine and TDF.

BackgroundAlbendazole is an orally administered broad-spectrum anthelmintic. Currently it is mostly used in the treatment of soil transmitted helminthes, hydatidosis and neurocysticercosis caused Taenia solium.Aim of the study. To develop and optimize a formulation of chewable albendazole tablet with improved dissolution rate.MethodologyThis study was specifically focused on formulation development which passes compatibility studies and optimization of the developed formulation. The formulations were evaluated on assay, dissolution, friability, hardness, weight variation, disintegration and similarity in comparison with the reference product on the market. Analysis was required to be undertaken by High performance thin layer chromatography (HPTLC) analytical methods. Design of Expert version 7 software was used for selection or making scientific decisions in selecting the best composition of the best formulation.ResultsFive formulations out of ten (F-6, F-7, F-8, F-9 and F10) had all parameters in acceptable range. On optimization, one formulation with independent variables, Sodium Laury Sulphate (SLS) 1.911%, polyvinyl pyrrolidone (PVP-K30) 3.128%, and Sodium Cross carmellose (CCM) 4.95% was selected out of ten predictions made with Design expert version 7.0. It was found that assay of the best formulation is 99.23% which was within the in-house assay specification 95–105%. Dissolution single point in 30 min was found to be 91.5% disintegration between 2-5 min and friability 0.45%.The optimized formulation was tested and found to be within the acceptable limits. The formulation was comparable to the reference product on the market with similarity factor (f2) 62 and difference factor (f1) of 6 at pH1.2.ConclusionA new generic albendazole tablet with improved dissolution rate was formulated, developed and optimized by using a wet granulation method.

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 ± P. Tibalinda et al. 248 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 region 400 to 1500 cm −1 (Finger print region) by a significant shift in Transmittance. Conclusion: It can be concluded that microcrystalline cellulose, cross linked sodium carboxymethyl cellulose, magnesium stearate and sodium carbxymethyl cellulose can be compressed together with Lamivudine and Tenofovir Disoproxil Fumarate (TDF) to produce a pharmaceutically acceptable solid dosage form, tablet. The produced tablets should be packed in moisture and light protective containers as Tenofovir Disoproxil Fumarate (TDF) has diester linkages which can be hydrolysed into the active drug Tenofovir in the presence of moisture.

Background Fish constitutes a nutritious food that deteriorates quickly when poorly preserved. Several biochemicals, including formaldehyde, naturally accumulate in the fish post-mortem. Apart from this natural formaldehyde, reports indicate the unlawful addition of formalin (37% formaldehyde solution) to the stored fish to prolong freshness. This is risky since formaldehyde is carcinogenic, genotoxic, and a potentiator of other carcinogens. Aim This study aimed to investigate both the freshness and the extent of contamination with formaldehyde of mackerel sold in Dar es Salaam. Methods A total of 60 mackerel samples were conveniently and equally obtained from the local markets, street vendors, and supermarkets in five districts of the Dar es Salaam region. Freshness was evaluated based on organoleptic characteristics. Formaldehyde analysis was done by High-Performance Liquid Chromatography (HPLC). Analysis of variance of formaldehyde concentration in fish flesh by source outlet and district was subsequently run. Results The analyzed mackerel samples had acceptable levels of freshness (2.46 ± 0.50) and a mean formaldehyde concentration of 10.89 ± 2.44 mg/kg. On average, the samples from supermarkets were the freshest (2.20 ± 0.21) however the most contaminated with formaldehyde (16.07 ± 4.68 mg/kg), while those from local markets were the least contaminated (3.91 ± 1.86 mg/kg) (p=0.000). Moreover, 0% (n=0), 20% (n=4), and 35% (n=7) of samples from local markets, street vendors, and supermarkets respectively, had formaldehyde concentrations above 20 mg/kg, the previously estimated highest concentration for natural formaldehyde in fish. Conclusion Mackerels found in Dar es Salaam have acceptable freshness but are substantially contaminated with formaldehyde. Whether this formaldehyde is natural or artificially added, our findings are inconclusive, given the conflicting global cut-off values for natural formaldehyde in fish. We, therefore, recommend a contextualized study to establish the time dynamics of formaldehyde formation in the stored fish. In the meantime, we advise the public to dwell on the local markets for fish rather than the supermarkets and street vendors.

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