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Drug-Excipient Interactions: Case Studies and Overview of Drug Degradation Pathways

American Journal of Analytical Chemistry 2016年第1期7卷 107-140页

作者： Kishore Kumar Hotha Swapan Roychowdhury veerappan subramanian Novel Laboratories Inc. Somerset NJ USA

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.

关键词： Drug Excipients Forced Degradation Impurities Adducts Degradation Pathways HPLC LC-MS/MS Synthesis Chemistry Characterization

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Drug-Excipient Interaction of Methylphenidate with Glycerin in Methylphenidate Oral Solution and Identification of its Transesterification Products by UPLC-MS/MS

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American Journal of Analytical Chemistry 2016年第2期7卷 151-164页

作者： Kishore Kumar Hotha Swapan Roychowdhury veerappan subramanian Novel Laboratories Inc. Somerset NJ USA

Reactions between active drug substances and excipients are of interest in the drug formulation process should be checked for the interactions during the storage conditions. Some excipients react with certain chemical groups in drug substances which will form new impurities in the finished product formulations. In the present paper transesterification reaction of methylphenidate with glycerin to form different structural isomeric products was described. These impurities identified in forced degradation studies, excipient compatibility studies and stability analysis of the finished product. Stability samples were analyzed and observed that about ~0.6% of the Methylphenidate content was transformed into methylphenidate-glycerin isomers within 3 Months at 40°C/75% RH and 18 Months at 25°C/60% RH conditions. Analysis of two lots of marketed preparations having expiry dates in 2012 and 2013 showed content of the Methylphenidate esters corresponding to ~0.6% of the declared Methylphenidate content. The samples of this impurity were investigated by HPLC, UPLC-MS/MS to generate the mechanism of the impurity formation.

关键词： Methylphenidate Oral Solution Glycerin Transesterification Excipient Interactions Forced Degradation

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Development of Better-Quality Assay Method for the Citric Acid and Sodium Citrate in Ophthalmic/Oral Solutions and Their Application to Deformulation Studies

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American Journal of Analytical Chemistry 2014年第17期5卷 1249-1260页

作者： Kishore Kumar Hotha Tejashkumar Patel Swapan Roychowdhury veerappan subramanian Novel Laboratories Inc. Somerset NJ USA

There were several techniques determined for the analysis of citrate and citric acid mixtures in the pharmaceutical dosage forms. Titration methods, photometric and ion chromatographic methods were used for their determination. These methods will restrict too many factors where the accurate quantification of citrate and citric acid is extremely challenging. Citric acid is the natural flavor used as a preservative for many pharmaceutical applications. Deformulation techniques used for the manufacturing of generic drugs require authentic data for their regulatory submissions. Simple accurate and reproducible validated method developed for the determination of citric acid and sodium citrate by titration followed by HPLC analysis. Free citric acid was determined by the titration method and total citric acid was determined by HPLC analysis. After subtracting the free citric acid from total citric acid content, citric acid present in the sodium citrate content was determined. Sodium citrate content was determined by applying sodium correction factor to the subtracted value of the citric acid. The results met all the validation parameters and the method was successfully measured the amount of citric acid and sodium citrate in the marketed ophthalmic/oral solutions.

关键词： Citric Acid Sodium Citrate Ophthalmic Solutions Oral Solutions Titration HPLC

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