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RESEARCH JOURNAL OF PHARMACY AND TECHNOLOGY
Year : 2021, Volume : 14, Issue : 1
First page : ( 96) Last page : ( 102)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2021.00018.4

Development of posaconazole delayed-release tablets by high shear melt granulation technique

Ramani Ketan B.1*, Dr. Patel Vipul2

1Research Scholar, School of Pharmacy, RK University, Rajkot, Gujarat, India.

2Associate Professor, School of Pharmacy, RK University, Rajkot, Gujarat, India.

*Corresponding Author E-mail: ketanbramani@gmail.com

Online published on 22 April, 2021.

Abstract

Pharmaceutical industries, particularly small and medium scale enterprises (SMEs) always prefer a manufacturing process that involves conventional equipment and devoid of solvents due to commercial, safety and ecological reasons. However, some drug products like Posaconazole delayed-release tablets are currently manufactured by the processes that require complex/costly equipment or a huge quantity of solvent and specifically skilled personnel. Aim of this study was to simplify delayed-release dosage form of Posaconazole, a BCS class IV drug having pH dependent solubility by the simple yet innovative manufacturing process. The study employed high shear melt granulation (HSMG) technique for manufacturing of drug product. Drug release controlling excipients namely Eudragit L100, triethylcitrate and Macrogol 6000 were selected, as these are suitable excipients for solventless processing at high temperature. Levels of drug release controlling ingredients were optimized using one factor at a time (OFAT) approach. Itwas revealed that drug release from the formulation was affected by the level of Eudragit L100, and Eudragit L100: Macrogol 6000 ratio. The optimized formulation was found satisfactory and reproducible with respect to all the studied pharmacotechnical parameters. The product was found stable at the accelerated storage conditions. In conclusion, Posaconazole delayed-release tablets can be prepared by conventional set of equipment, which are available at most of the pharmaceutical SME by using the explored HSMG technique.

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Keywords

Posaconazole, Melt granulation, High shear, Solventless, Delayed-release, Solid dispersion.

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