Development a formula of paracetamol 325mg capsule to practices in faculty of pharmacy, Nguyen Tat Thanh University

Abstract

     The study is to develop a formula for paracetamol 325 mg capsule and evaluate some quality criteria of 325 mg paracetamol capsule and propose product quality criteria. The result has selected the filler excipient being Avicel: lactose with a ratio of 1:1, the binder excipient being PVP K30, thereby building a semi-granulated formula with ingredients being paracetamol 90 %, lactose 3 %, Avicel 3 %, PVP K30 4 %, ethanol 70 %. In addition, the study investigated the effects of filler-lubricant excipients and selected the appropriate excipient mixture of Avicel: magnesium stearate (1:1) to complete the capsule formulation including: semi-granulated paracetamol equivalent to 325 mg of paracetamol, Avicel: magnesium stearate (1:1) just enough for 1 tablet. After that, the batch size was increased to maximize the capacity of the capsule packing machine shows that the qualities still ensure. Then, a 10-step standard operating procedure for capsule and a number of quality criteria for the preparation was developed, including: appearance, determination of weight uniformity, determination of active content, the amount of drug release and dissolution. This is a resource to build lessons and improve the training program of Faculty of Pharmacy - Nguyen Tat Thanh University.