Abstract
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. Recent developments in the understanding of the degradation pathways further impact methodologies used in the pharmaceutical industry for potential stability assessment. The formation of drug excipient adducts was very common based on the sensitive chemical moieties in the drugs and the excipients. 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. Identification of drug degradation in presence of excipients/excipient impurities requires extensive knowledge and adequate analytical characterization data. Systematic literature review and understanding about the drug formulation process, give you a smooth platform in establishing the finished product in the drug market. 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.
Highlights
Excipients are included in dosage forms to aid manufacture, administration or absorption
Analytical development should ensure any unknown peaks formed during the drug excipient compatibility studies
Thorough monitoring of unknown impurities and its origin during drug development process reduces the delay in the product filings [4] [5]
Summary
Excipients are included in dosage forms to aid manufacture, administration or absorption. Excipients may have functional groups that interact directly with active pharmaceutical ingredients They may contain impurities or residues or form degradation products that in turn cause decompositions of the drug substance. Residue Peroxides Antioxidants Aldehydes, reducing sugars Benzaldehyde Aldehydes, peroxides, organic acids Lignin, hemicelluloses, water Formaldehyde Heavy metals Alkaline residues Alkaline residues Glyoxal work of drug excipient interactions from our internal findings is reported as case study examples for methylphenidate and fluphenazine decanoate. The origin of these reactive impurities and their potential chemical reactions with the susceptible APIs were identified. Stratagems to mitigate the potential incompatibilities are reviewed
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