![]() ![]() ![]() The polysorbates used in the formulation of biopharmaceuticals are mixtures of different fatty acid esters with the monolaurate fraction of polysorbate 20 making up only 40–60% of the mixture and the monooleate fraction of polysorbate 80 making up >58% of the mixture. The polysorbates are amphipathic, nonionic surfactants composed of fatty acid esters of polyoxyethylene sorbitan being polyoxyethy-lene sorbitan monolaurate for polysorbate 20 and polyoxyethylene sorbitan monooleate for polysorbate 80. Polysorbates 20 and 80 (Tween 1 20 and Tween 1 80) are used in the formulation of biotherapeutic products for both preventing surface adsorption and as stabilizers against protein aggregation. ![]() This paper discusses mechanistic basis of known drug-excipient interactions with case studies and provides an overview of common underlying themes in solid, semisolid and parenteral dosage forms. Systematic literature review and understanding about the drug formulation process, give you a smooth platform in establishing the finished product in the drug market. Identification of drug degradation in presence of excipients/excipient impurities requires extensive knowledge and adequate analytical characterization data. The formation of the impurities was not limited to drug related impurities but there were several possibilities of the drug-excipient adduct formations as well as excipient impurities reaction with Active Pharmaceutical Ingredients. The formation of drug excipient adducts was very common based on the sensitive chemical moieties in the drugs and the excipients. Recent developments in the understanding of the degradation pathways further impact metho-dologies used in the pharmaceutical industry for potential stability assessment. The objective of the current research article is to provide a comprehensive review of excipients impact on the stability of the drug product and their implications during the product development. ![]()
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