Drug excipient interactions and incompatibilities pdf

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drug excipient interactions and incompatibilities pdf

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Drug-excipient compatibility studies represent an important phase in drug development. Before a drug substance is formulated into the desired dosage form, there is need for the formulation scientist to fully consider the chemical structure of the drug substance, the type of delivery system required and the proposed manufacturing process. Drug substances are usually combined with excipients which serve different and specialized purpose. Although excipients are pharmacologically inert, they can undergo chemical reactions and physical interactions with drug substances under favourable environmental conditions.

Drug-excipient interaction and its importance in dosage form development

Scientific Research An Academic Publisher. Excipients are included in dosage forms to aid manufacture, administration or absorption. Excipients can initiate, propagate or participate in chemical or physical interactions with an active, possibly leading to compromised quality or performance of the medication. Chemical interaction can lead to degradation of the active ingredient, theory by reducing the amount available for the therapeutic effect; reaction products may compromise safety or tolerance. Physical interactions can affect the rate of dissolution, uniformity of dose or ease of administration. Understanding the chemical and physical nature of excipients, the impurities or residues associated with them and their interaction with actives as well as with each other is the important phenomenon in the drug excipient interaction process [1] -[3].

Crystal Transition and Drug-excipient Compatibility of Clarithromycin in Sustained Release Tablets

Abstract: Estriol , is a major urinary estrogen hormone. In this study, thermodynamic and spectroscopic data obtained from pure estriol and mixtures of pure estriol with pharmaceutical excipients were compared. Preliminary studies using thermal and spectroscopic technique implied the compatibility of mannitol, calcium phosphate dibasic, sucrose, butylated hydroxyanisole, cellulose, lactose, magnesium stearate, talc and sodium carboxymethyl cellulose with the drug estriol. As a result of the experimental study, there is incompatibility of estriol-mannitol, estriol-sucrose, estriol-lactose and estriol-magnesium stearate. Zotero Mendeley EndNote.

Skip to search form Skip to main content You are currently offline. Some features of the site may not work correctly. Anitha and V. Rao and T. Mamatha and J. Rao Published Chemistry. Excipients are included in dosage forms to aid manufacture, administration or absorption.

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DOI : Background: Clarithromycin is widely used for infections of helicobacter pylori. Clarithromycin belongs to polymorphic drug. Crystalline state changes of clarithromycin in sustained release tablets were found.

The results show that two multivariate techniques, principal component analysis PCA and cluster analysis CA , can be successfully used for interpretation of TG traces, while the TG is used alone as a screening technique to assess compatibility. The results obtained by using TG analysis, supported by PCA and CA, were approved by those of differential scanning calorimetry, infrared spectroscopy and X-ray powder diffraction. Preformulation stage of solid dosage formulations includes detection of possible interactions of an active pharmaceutical ingredient API with excipients [ 1 — 4 ].

To facilitate the development of novel drug delivery systems, the demand of new excipients has been increased.


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