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Quality by design (QbD) refers to a new approach to product development that could increase efficiencies, provide regulatory relief and flexibility, and offer important business benefits throughout the product life cycle. QbD is increasingly becoming an important and widely used technique in the pharmaceutical industry. QbD can be considered to be system-based approach to the design, development, and delivery of any product or service to a consumer. It is an approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control. Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities, and steps involved in QbD of pharmaceutical products are described. The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Quality cannot be tested into products, but quality should be built in by design. It includes the quality target product profile, critical quality attributes, and key aspects of QbD. It also gives comparison between product quality by end product testing and product quality by QbD. The foundation of QbD is ICH guidelines. Hence, if we identify the cause and effect relationship between the various inputs and responses by carefully designed experiments, we can control the quality of the product by simply controlling the inputs such as raw material specifications or process parameters.

Background: Oral sustained release gastroretentive dosage forms offer many advantages for drugs having absorption from upper gastrointestinal tract and improve the bioavailability of medications that are characterized by narrow absorption window. The aim of current study was to design sustained release bioadhesive gastroretentive dosage form of ofloxacin. Materials and Methods: A 3 2 full factorial design was employed to systematically study the drug release profile and bioadhesive strength. Carbopol 934P and HPMC K100M were selected as the independent variables. Compatibility between drug and polymer was tested by fourier transform infrared (FTIR) and X-ray diffraction (XRD) techniques. Tablets were prepared by direct compression and were evaluated for tablet characteristics, swelling study, adhesion strength, percent drug released, radiographic imaging study and stability study. The optimized formulation was then compared with marketed formulation (Oflin OD®). Results: Tablets prepared showed good tablet characteristics, optimum swelling property, and good adhesion strength with high detachment force. Most of the formulations including the optimized formulation followed Higuchi kinetics and the drug release mechanism was found to be anomalous. Radiographic image proved that tablet remains intact in its structural integrity and shape in stomach up to 24 h. The short-term accelerated stability testing was carried out for the optimized formulation, and results revealed that drug content, in-vitro dissolution and all other parameters were within acceptable limits. Conclusion: Thus, the prepared bioadhesive gastroretentive ofloxacin tablet may prove to be a potential candidate which increases the bioavailability of ofloxacin for any intragastric condition.

Background: The main aim of this study was to develop a gastroretentive, multiple-unit floating drug delivery system for a drug which is poorly absorbed from the lower gastrointestinal tract. Such a dosage form may provide an extended retention of drug in the upper gastrointestinal tract resulting in enhanced absorption and improved bioavailability. Materials and Methods: Microspheres were prepared by the emulsion solvent diffusion method. Four different ratios (1:1, 1:2, 1:3, and 1:4) from each polymer, i.e., Eudragit RL 100 (E1–E4) and cellulose acetate (C1–C4) were prepared. Results: Hollow microspheres were characterized by particle size using optical microscopy. The in vitro release data obtained for the formulations E1–E4 and C1–C4 showed good entrapment efficiency, good percentage buoyancy, and prolonged drug release. The in vitro drug release showed the highest regression coefficient values for Higuchi's model, indicating diffusion to be the predominant mechanism of drug release. The surface and cross-sectional morphology of the formulations E1-A and C1-A were determined using scanning electron microscopy. Conclusions: Thus, prepared floating hollow microspheres of famotidine may prove to be potential candidates for the multiple-unit drug delivery device adaptable for any intragastric condition.