Crystallinity of Omeprazole in Various Film Polymers

Sarisuta, Narong; Kumpugdee, Mont

doi:10.1211/146080800128735403

Cited by 1 publication

(1 citation statement)

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“…Several other studies have shown the ability of HPMC to decrease the crystallinity of the drug such as albendazole, felodipine, nicotinamide, acetaminophen, carbamazepine and trans-resveratrol by incorporating into the drug crystal lattice, having molecular interaction with the drug molecules or adsorbing onto the surface of the drug, thereby preventing crystal growth (9)(10)(11)(31)(32)(33). However, the addition of HPMC into the formulation does not necessarily lead to a reduction in drug crystallinity as seen in other studies on omeprazole and prednisolone (34,35).…”

Section: Crystallinity Of Mnz In Spray-congealed Microparticlesmentioning

confidence: 94%

Influence of Hydroxypropyl Methylcellulose on Metronidazole Crystallinity in Spray-Congealed Polyethylene Glycol Microparticles and Its Impact with Various Additives on Metronidazole Release

Heng

Chan

2015

AAPS PharmSciTech

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Abstract. The purpose of this study was to investigate the effect of a hydrophilic polymer, hydroxypropyl methylcellulose (HPMC), on the crystallinity and drug release of metronidazole (MNZ) in spraycongealed polyethylene glycol (PEG) microparticles and to further modify the drug release using other additives in the formulation. HPMC has been used in many pharmaceutical formulations and processes but to date, it has not been employed as an additive in spray congealing. Crystallinity of a drug is especially important to the development of pharmaceutical products as active pharmaceutical ingredients (APIs) are mostly crystalline in nature. A combination of X-ray diffractometry, differential scanning calorimetry, Raman spectroscopy and Fourier transform-infrared spectroscopy (FT-IR) spectroscopy was employed to investigate the degree of crystallinity and possible solid-state structure of MNZ in the microparticles. The microparticles with HPMC were generally spherical. Spray congealing decreased MNZ crystallinity, and the presence of HPMC reduced the drug crystallinity further. The reduction in MNZ crystallinity was dependent on the concentration of HPMC. Smaller HPMC particles also resulted in a greater percentage reduction in MNZ crystallinity. Appreciable modification to MNZ release could be obtained with HPMC. However, this was largely attributed to the role of HPMC in forming a diffusion barrier. Further modification of drug release from spray-congealed PEG-HPMC microparticles was achieved with the addition of 5% w/w dicalcium phosphate but not with magnesium stearate, methyl cellulose, polyvinylpyrrolidone, silicon dioxide and sodium oleate/citric acid. Dicalcium phosphate facilitated formation of the diffusion barrier.

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