Polymeric hydrophilic matrices are widely used for controlled-release preparations. The process of drug release is controlled by matrix swelling or polymer dissolution. It has been shown that the swelling of guar gum is affected by concentration of drug and viscosity grade of the polymer. This study examines the mechanism of behavior of guar gum in a polymer-drug matrix. The swelling action of guar gum, in turn, is controlled by the rate of water uptake into the matrices. An inverse relationship exists between the drug concentration in the gel and matrix swelling. This implies that guar gum swelling is one of the factors affecting drug release. The swelling behavior of guar gum is therefore useful in predicting drug release.
Matrix-based controlled-release niacin tablets were formulated using guar gum. The effect on the in vitro dissolution profile was examined using variable guar gum content in the formulation. It was observed that the dissolution profile declined with the increase in the guar gum content in the tablet. The in vitro dissolution profile was also observed under different pH conditions and there was no marked change. The moisture content of granules also did not cause any considerable change in dissolution profile. Three different strength Niacin controlled-release tablets, including 500 mg, were prepared and it was found that applying the same variables of different guar gum content and moisture content of granules resulted in a very insignificant change in the in vitro dissolution profile. The experimental formulation compared well with commercial products and met the proposed standards for controlled-release products.
Particle size/shape characterization of active pharmaceutical ingredient (API) is integral to successful product development. It is more of a correlative property than a decision-making measure. Though microscopy is the only technique that provides a direct measure of particle properties, it is neglected for reasons like non-repeatability and non-reproducibility which is often attributed to a) fundamental error, b) segregation error, c) human error, d) sample randomness, e) sample representativeness etc. Using the "Sucrose" as model sample, we propose "analytics continuum" approach that integrates optical microscope PSD measurements complimented by NIR spectroscopy-based trending analysis as a prescreening tool to demonstrate sample randomness and representativeness. Furthermore, plethora of statistical tests are utilized to infer population statistics. Subsequently, an attribute-based control chart and bootstrap-based confidence interval was developed to monitor product performance. A flowchart to serve as an elementary guideline is developed, which is then extended to handle more complex situations involving API crystallized from two different solvent systems. The results show that the developed methodology can be utilized as a quantitative procedure to assess the suitability of API/excipients from different batches or from alternate vendors and can significantly help in understanding the differences between material even on a minor scale.
Starch and its derivatives are one of the significant excipients used in the pharmaceutical formulations due to their multi-purpose functionalities. The purpose of this study is two-fold: (1) Firstly, to propose a systematic approach in understanding the material properties of a starch derivative (pregelatinised starch/PGS) using analytical ‘toolbox’ as part of ‘alternative supplier sourcing’, and secondly (2) To demonstrate the effect of PGS from different vendors on the tablet disintegration using model formulations. Contextually, a two-tier characterisation procedure is generally considered as a prerequisite for establishing the sameness of the material obtained either from different batches or from various vendors. Primarily, the sameness between typical quality-control tests and compendial requirements are to be established. If similar, then sameness between the functional characteristics is to be established. In this context, the PGS from two vendors met the specifications, and there were no differences for the test results in the certificates of analysis. However, when subjected to functionality assessment, the two lots were found to be distinctly different. The influence of the functional property variations was further exemplified from viscosity results of raw material. Furthermore, this difference was even more evident when the model formulations were subjected to disintegration testing. The similarity in compendial tests but significant differences in functionality characteristics for the PGS of two vendors can be unravelled by considering variations in particle size, crystallinity, starch retrogradation and these changes are potentially attributed to the differences in the gelatinisation procedures adopted by the vendors.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.