Drug-excipient compatibility testing of cilostazol using FTIR and DSC analysis

Issue Date

12-2023

Abstract

Cilostazol possesses pharmacological restrictions, such as its absorption being limited by its dissolution rate, and formulation studies must be employed accordingly to generate an optimized formulation. A drug-excipient compatibility analysis is conducted to determine any interactions that may affect the formulation in order to guarantee the stability, bioavailability, and manufacturability of solid dosage forms. To identify any incompatibilities, cilostazol alone and in combination with the individual excipients such as microcrystalline cellulose, crospovidone, magnesium stearate, isopropyl alcohol, sodium lauryl sulfate, polyvinylpyrrolidone K30, and corn starch were subjected to Fourier-transform infrared spectroscopy (FTIR) equipped with an attenuated total reflectance method and heat-flow differential scanning calorimetry (DSC) with a temperature ranging from 30–400 °C at 10 °C/min ramp rate. The FTIR analysis of cilostazol alone and combined with excipients revealed no evidence of chemical or physical instability. Minor changes in the appearance of the absorbance bands in the FTIR comparison can be seen primarily due to the chemical characterization of the excipients, but the characteristic peaks of cilostazol were still present. As for DSC compatibility analysis, the % difference in cilostazol's principal peak temperature alone and with excipients showed no significant change. This implies that no incompatibilities exist between cilostazol and the excipients.

Source or Periodical Title

Philippine Journal of Science

ISSN

0031-7683

Volume

152

Issue

6A

Page

2129-2137

Document Type

Article

Frequency

bi-monthly

Physical Description

illustrations; graphs; tables; references

Language

English

En – AGROVOC descriptors

DRUGS; HYPERTENSION; CHEMICOPHYSICAL PROPERTIES; STABILITY; CHEMICAL COMPOUNDS; MEDICINAL PROPERTIES; BULKING AGENTS; ANALYTICAL METHODS; CHEMICAL ANALYSIS; SPECTROSCOPY; FOURIER ANALYSIS; DIFFERENTIAL SCANNING CALORIMETRY; THERMAL ANALYSIS; PHARMACOLOGY

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