Selection of excipients for extended release formulations of glipizide through drug–excipient compatibility testing

Verma, Rajan K; Garg, Sanjay

doi:10.1016/j.jpba.2005.02.026

Cited by 126 publications

(47 citation statements)

References 14 publications

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“…Physical interactions can alter physicochemical properties of the active ingredient, such as solubility, dissolution rate and finally bioavailability [5,6]. There is no universally accepted protocol in the literature or issued by regulatory agencies for evaluating API-excipient compatibility or interactions [7,8]. Methods for robust characterisation of API-excipient interactions are limited, timeconsuming and labour intensive due to the number of variables that will need to be incorporated into the study, e.g.…”

Section: Introductionmentioning

confidence: 99%

Compatibility studies of hydrocortisone with excipients using thermogravimetric analysis supported by multivariate statistical analysis

Rojek

Wesołowski

2016

J Therm Anal Calorim

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Application of thermogravimetry (TG) alone to study compatibility/incompatibility of active pharmaceutical ingredients (APIs) with excipients yields to misleading results due to overlapping of the thermal stages in the course of decomposition of both ingredients and their pharmaceutical mixtures. Hence, the purpose of this study was to assess the usefulness of multivariate statistical analysis as a supporting tool for interpretation of the TG traces during assessing compatibility of hydrocortisone as an API with selected excipients (mannitol, starch, lactose, methylcellulose, b-cyclodextrin, meglumine, chitosan, magnesium stearate and polyvinylpyrrolidone). 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. Incompatibilities were only found in mixtures of hydrocortisone with magnesium stearate and b-cyclodextrin.

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Section: Introductionmentioning

confidence: 99%

Compatibility studies of hydrocortisone with excipients using thermogravimetric analysis supported by multivariate statistical analysis

Rojek

Wesołowski

2016

J Therm Anal Calorim

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“…The minor changes in the melting endotherm of the mixture could be attributed to the mixing of active and excipient, and not indicate potential incompatibility. Variations in the enthalpy values for the binary mixtures can be attributed to some heterogeneity in the small samples used for the experiments (3-4 mg) (Verma et al, 2005). The X-Ray diffractometry showed that pure diclofenac potassium, diclofenac potassium within PM and diclofenac potassium in SD were crystalline in nature (Figure 3).…”

Section: Resultsmentioning

confidence: 99%

Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with Mannitol.

Han¹,

Faudone²,

Zitto³

et al. 2017

J App Pharm Sci

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Diclofenac potassium is an anti-inflammatory agent classified as a class II drug as per the biopharmaceutical classification system (BCS). The poor dissolution rate of water-insoluble drugs is still a major problem confronting the pharmaceutical industry. There are several techniques to enhance the dissolution of poorly soluble drugs. Methods available include salt formation, micronization and addition of solvent or surface active agents. The objective of the present work is to improve the dissolution profile of diclofenac potassium by formation of a physical mixture and a solid dispersion with mannitol. The solid dispersion was prepared by solvent method using ethanol/water. As diclofenac potassium melts with decomposition, the compatibility study with mannitol was done with the acid form by differential scanning calorimetry (DSC). The dissolution properties and physicochemical properties of diclofenac potassium:mannitol physical mixture and solid dispersion were investigated by Powder X-ray Diffraction (PXRD), Fourier Transform Infrared Spectroscopy (FTIR), Scanning Electron Microscopy (SEM) and dissolution test. This study shows that the dissolution rate of diclofenac potassium can be enhanced considerably by formulating it with mannitol, as a physical mixture or as a solid dispersion although crystallinity was maintained.

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“…Drug-excipient compatibility testing at an early stage helps in the selection of excipients that increases the probability of developing a stable dosage form 10 . Compatibility studies of drug with excipients were performed under different storage conditions for one month.…”

Section: Compatiability Studiesmentioning

confidence: 99%

Design, in Vitro Evaluation and in Vivo Studies of Novel Delayed Release Tablets of Pantoprazole

Choudhry¹,

Patel²,

Jain³

et al. 2012

Int J of Biomed & Adv Res

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In an effort to reduce production costs, a simple, direct compression delayed release formulation consisting of pantoprazole was investigated. Pantoprazole is a proton pump inhibitor belongs to group of benzimidazole. It is very efficient for the treatment of gastric and duodenum ulcers. Even in solid state pantoprazole is sensitive to heat, humidity, light and especially to substances containing an acidic group. For such types of drugs, enteric coating added to the formulation tends to avoid the stomach's acidic exposure, delivering them instead to a basic pH environment where they do not degrade, and give their desired action. Subcoating is desirable to protect the enteric coating. Opadry and Acryl-EZE systems have been utilized for subcoating and enteric coating respectively. Delayedrelease tablets with good physical, mechanical and technological properties were obtained with use of different combinations of diluents, binders, superdisintegrants and lubricants. A comparative kinetic study of the present tablets and commercial tablets was established. The value for the similarity factor (f2 = 71.6) suggested that the dissolution profile of the present two delayed-release oral dosage forms are similar. Hixon-Crowell (erosion) kinetic profiles were achieved.

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Selection of excipients for extended release formulations of glipizide through drug–excipient compatibility testing

Cited by 126 publications

References 14 publications

Compatibility studies of hydrocortisone with excipients using thermogravimetric analysis supported by multivariate statistical analysis

Compatibility studies of hydrocortisone with excipients using thermogravimetric analysis supported by multivariate statistical analysis

Physicochemical Characterization of Physical Mixture and Solid Dispersion of Diclofenac Potassium with Mannitol.

Design, in Vitro Evaluation and in Vivo Studies of Novel Delayed Release Tablets of Pantoprazole

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