Exploring an Industrial Manufacturing Process of a Drug Containing Tenofovir

Background: Tenofovir is an antiretroviral drug, a reverse transcriptase inhibitor formulated as tenofovir disoproxil in its saline form, which acts as a prodrug of tenofovir. Its clinical use is indicated in the treatment of Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV). In this work, a solid oral formulation in coated tablets of tenofovir disoproxil has been designed, using an appropriate manufacturing process to overcome any possible problems of stability, compressibility and bioavailability. Materials and Methods: Compatibility studies have been carried out through thermal analysis (Differential Scanning Calorimetry, DSC) and infrared spectroscopy (FT-IR), pharmacotechnical characterization through analysis of flow time, angle of repose, Hausner Ratio and Carr Index, and Pharmacochemical characteristics (weight, hardness, disintegration, thickness and friability). Results: In the pharmaceutical industry, the selection of the most correct tablet production method depends on the individual characteristics of the components and their ability to flow, compress and disintegrate. In this work, a wet granulation process was selected, key to achieving specific granulation, followed by compression and film coating. DSC and FT-IR spectral studies demonstrated that there is no interaction between the active pharmaceutical ingredient and the excipients. Excellent results were found in the pharmacotechnical and physicochemical characterization to obtain the tablets, demonstrating the adequate production process. Conclusion: Tenofovir film coated tablets were successfully formulated using the wet granulation compression method and film coating. The methodologies used demonstrated the appropriate selection of the excipients in terms of physical and chemical compatibility and the suitability of the mixture for use in the process of obtaining the tablet.