Effect of experimental design on the prediction performance of calibration models based on near-infrared spectroscopy for pharmaceutical applications.
Abstract Near-infrared spectroscopy (NIRS) is a valuable tool in the pharmaceutical industry, presenting opportunities for online analyses to achieve real-time assessment of intermediates and finished dosage forms. The purpose of this work was to investigate the effect of experimental designs on prediction performance of quantitative models based on NIRS using a five-component formulation as a […]
Functionality of disintegrants and their mixtures in enabling fast disintegration of tablets by a quality by design approach.
Abstract Investigation of the effect of disintegrants on the disintegration time and hardness of rapidly disintegrating tablets (RDTs) was carried out using a quality by design (QbD) paradigm. Ascorbic acid, aspirin, and ibuprofen, which have different water solubilities, were chosen as the drug models. Disintegration time and hardness of RDTs were determined and modeled by […]
Design and optimization of bilayered tablet of Hydrochlorothiazide using the Quality-by-Design approach.
Abstract AIM: The aim of the present study is to develop an optimize bilayered tablet using Hydrochlorothiazide (HCTZ) as a model drug candidate using quality by design (QbD) approach. INTRODUCTION AND METHOD: The bilayered tablet gives biphasic drug release through loading dose; prepared using croscarmellose sodium a superdisintegrant and maintenance dose using several viscosity grades of hydrophilic […]
Development of Tablet Formulation of Amorphous Solid Dispersions Prepared by Hot Melt Extrusion Using Quality by Design Approach.
Abstract The objective of the study was to identify the extragranular component requirements (level and type of excipients) to develop an immediate release tablet of solid dispersions prepared by hot melt extrusion (HME) process using commonly used HME polymers. Solid dispersions of compound X were prepared using polyvinyl pyrrolidone co-vinyl acetate 64 (PVP VA64), Soluplus, […]
Quality by Design (QbD) Approach for Development of Co-Processed Excipient Pellets (MOMLETS) By Extrusion-Spheronization Technique.
Abstract BACKGROUND: Microcrystalline cellulose (MCC) is an excellent excipient for production of pellets by extrusion spheronization. However, it causes slow release rate of poorly water soluble drugs from pellets. Co-processed excipient prepared by spray drying (US 4,744,987; US 5686107; WO 2003/051338) and co-precipitation technique (WO 95/17831) are patented. OBJECTIVE: The objective of present study was to […]