An active film-coating approach to enhance chemical stability of a potent drug molecule

@article{Desai2012AnAF,
  title={An active film-coating approach to enhance chemical stability of a potent drug molecule},
  author={Divyakant S. Desai and Venkatramana M. Rao and Hang Guo and Danping Li and Daniel Stein and Frank Y. Hu and Chris Kiesnowski},
  journal={Pharmaceutical Development and Technology},
  year={2012},
  volume={17},
  pages={227 - 235}
}
Peliglitazar, a PPAR α/γ agonist, was found to undergo acid as well as base catalyzed degradation. The acid catalyzed degradation led to the formation of benzylic alcohol and glycine carbamate and the base catalyzed degradation led to formation of p-hydroxyanisole and an amine degradant. In capsule formulations, the capsules with the lowest drug-loading exhibited maximum instability even at 25°C/60% RH storage condition. Incorporation of pH-modifiers to maintain ‘micro-environmental pH’ acidic… 
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14 Citations
Background Citations
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14 Citations

Effect of coating excipients on chemical stability of active coated tablets
TLDR
Higher stability of triacetin systems over PEG systems was attributed to lower solubility and mobility of peliglitazar in HPMC compared with the PVA-based coating, while for the same plasticizer/detackifier, higher stability of H PMC over PVA, based on the overall stability for the film-forming polymer-plasticizer/ Detackifier combination.
Active coating of immediate-release evogliptin tartrate to prepare fixed dose combination tablet with sustained-release metformin HCl.
Reactive Impurities in Excipients
Reactive impurities in pharmaceutical excipients can affect drug product instability, leading to decreased product performance, loss in potency, and/or formation of potentially toxic degradants. The…
An evaluation of process parameters to improve coating efficiency of an active tablet film-coating process.
EFFECT OF FORMULATION AND PROCESS VARIABLES ON DEGRADATION PRODUCTS OF LOVASTATIN IN TABLET DOSAGE FORM
Objective: Quantification of degradation products in drug substances and products is the most challenging tasks in pharmaceutical industries nowadays. Systematic study on the degradation products of…
Pharmaceutical application and development of fixed-dose combination: dosage form review
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This review provides discussions of the FDC application in variety of disease using various formulation technologies that consider characteristics of each active pharmaceutical ingredient (API) in FDC to maximize the benefits and overcome the challenges of developing FDC products.
Reactive Impurities in Excipients: Profiling, Identification and Mitigation of Drug–Excipient Incompatibility
TLDR
In this review paper, excipient impurity classes are categorized into six major classes, including reducing sugars, aldehydes, peroxides, metals, nitrate/nitrite, and organic acids, and the potential reactions with drug candidates of these impurities are reviewed.
Formulation design, challenges, and development considerations for fixed dose combination (FDC) of oral solid dosage forms
TLDR
An overview to pharmaceutical scientists about recent trends in the formulation development of the FDC products is given and decision trees to select most optimum formulation development strategy are provided.
Optimization of Critical Quality Attributes in Tablet Film Coating and Design Space Determination Using Pilot-Scale Experimental Data
TLDR
The results indicate that all the process responses are affected by changing the inlet air flow rate, temperature, and suspension spray rate, which facilitates the quality by design implementation of continuous pharmaceutical manufacturing.
A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms
Abstract This paper proposes the development of a drug product Manufacturing Classification System (MCS) based on processing route. It summarizes conclusions from a dedicated APS conference and…
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