Quality-by-design approach for the development of telmisartan potassium tablets

Abstract

A quality-by-design approach was adopted to develop telmisartan potassium (TP) tablets, which were bioequivalent with the commercially available Micardis (telmisartan free base) tablets. The dissolution pattern and impurity profile of TP tablets differed from those of Micardis tablets because telmisartan free base is poorly soluble in water. After identifying the quality target product profile and critical quality attributes (CQAs), drug dissolution, and impurities were predicted to be risky CQAs. To determine the exact range and cause of risks, we used the risk assessment (RA) tools, preliminary hazard analysis and failure mode and effect analysis to determine the parameters affecting drug dissolution, impurities, and formulation. The range of the design space was optimized using the face-centered central composite design among the design of experiment (DOE) methods. The binder, disintegrant, and kneading time in the wet granulation were identified as X values affecting Y values (disintegration, hardness, friability, dissolution, and impurities). After determining the design space with the desired Y values, the TP tablets were formulated and their dissolution pattern was compared with that of the reference tablet. The selected TP tablet formulated using design space showed a similar dissolution to that of Micardis tablets at pH 7.5. The QbD approach TP tablet was bioequivalent to Micardis tablets in beagle dogs.

Ucuùba (Virola surinamensis) Fat-Based Nanostructured Lipid Carriers for Nail Drug Delivery of Ketoconazole: Development and Optimization Using Box-Behnken Design

“…Since the introduction at the beginning of the new millennium of the Quality-by-Design approach, the pharmaceutical sector has started using the design of the experiment as a statistical tool to maximize process knowledge and efficiently optimize product quality characteristics [38,39]. This approach has been applied to the manufacturing process of several dosage forms, including as tablets [40], pellets [41], semisolid formulations [42] and spray-dried powders to be used in dry powder inhalers [43].…”

Quality-by-Design Approach for the Development of Nano-Sized Tea Tree Oil Formulation-Impregnated Biocompatible Gel with Antimicrobial Properties

“…To achieve the desirable characteristics of LNF, we used a quality-by-design (QbD) approach to understand how the process can affect the final product. QbD provides manufacturing controls that allow us to identify and optimize the process and formulation, according to the statistical experimental designs such as response surface [26]. This convenient process allows us to achieve high-quality specifications by increasing the process capability and manufacturing efficiencies (spontaneous emulsification with less surfactant and co-surfactant).…”

Quality by Design Applied Development of Immediate-Release Rabeprazole Sodium Dry-Coated Tablet

“…Next, 50 mL of the filtrate was obtained and titrated with hydrochloric acid with 0.1 M sodium hydroxide solution (pH measurement method) with an endpoint of pH 3.5. A blank was also generated in the same manner and the acidneutralizing capacity was calculated as follows: The quality target product profile (QTPP) is the basis for formulation and production process design in drug development [36][37][38]. Parameters include clinical use, route of administration, formulation, delivery system, content, container and packaging, API release or delivery, characteristics affecting pharmacokinetic properties, sterility, purity, stability, and dissolution ( Table 1).…”