Hydatid disease occurs in most areas of the world and currently affects about one million people. Albendazole is an orally administered broad spectrum anthelmintic drug approved by US FDA in 1996. Literature review suggests Albendazole is low solubility compound and most of the studies were performed to improve the solubility with traditional approach of product development. The present study was aimed to apply Design of Experiments (DoE) in the development and optimization of drug release from new Albendazole tablets using three factor two level (23) full factorial designs with integrated Quality be Design (QbD) approach. New Albendazole tablets were formulated using micronized grade of the Albendazole active and excipients were selected inline with market reference product. Quality target product profile (QTPP) and Critical quality attributes (CQAs) were designed. Risk assessment was used to identify the Formulation variables impacting CQA dissolution. The amount of Formulation variables were optimized on the basis of drug release profiles at 15 minutes and 30 minutes of different formulation batches manufactured based on 23 full factorial design. Tablets were prepared by wet granulation technique and evaluated for various physicochemical parameters and in vitro drug release. Formulation trials dissolution results at 15 minutes and 30 minutes were evaluated to derive the concentration of Formulation variables which will achieve the release of more than 80%. Analysis of variance (ANOVA) analysis, Pareto chart and Contour plot were used to predict the values of formulation variables and their effect on dissolution.  Updated risk assessment of the Formulation Variables was performed and justification was provided for reduction of risk from medium to low level. Optimized formulation from DOE had comparable dissolution profile with market reference tablet. Stability studies of new Albendazole tablets 200 mg were conducted at ICH accelerated conditions and found to be stable. Thus studies revealed that full factorial experimental design could efficiently be applied for optimization of formulation variables affecting drug release. New Albendazole tablets 200 mg successfully formulated with application of the integrated quality by design (QbD) and design of experiment (DOE) approach and thereby achieved comparable release profile with market reference product.

A simple, rapid, economic, accurate and precise reverse phase high performance liquid chromatography method for analysis of Etodolac was developed and validated according to ICH guidelines. The quantification of the drug was carried using photodiode array detector. RP-C18 column was used in isocratic mode, with 60:40 ratio of Acetonitrile: Methanol as a mobile phase. The flow rate was set to 1.0 ml/min. The UV detection was carried out at wavelength 226 nm wavelength was selected for analysis. The method was validated by performing recovery study.

Over the last few decades, hot melt extrusion (HME) has found extensive adaptability and utility as a viable drug delivery option in the pharmaceutical industry. HME has already been validated as a robust, novel technique mainly used for the correction of solubility and bioavailability of poorly soluble drugs. In line with the scope of the current issue, this review appraises the value of HME as a means of solubility enhancement of BCS class II drugs and presents an influential tool for the manufacturing or production of drugs or chemicals. The drug development process can be shortened with the use of hot melt extrusion technology, and the application of this process to analytical technology can ease the manufacturing process. This review focuses on the tooling, utility, and manufacturing aspects associated with hot melt extrusion technology.

Quality by Design (QbD) is a methodical approach to pharmaceutical product development that begins with predefined objectives and emphasizes product and process comprehension and process control based on sound science and quality risk management. Pharmaceutical development should lead to the design a quality product and its manufacturing process to meet the QTPP and CQA parameters. To arrive at the robust product development QbD articulation is important which is missing in most of the reviews. This review articulates the QbD elements in the product development. QbD process stars with identification of QTPP and source CQA from QTPP. CMAs and CPPs are derived with risk assessment from the product ingredients and process. Their impact on the CQAs can be studies with DoE tools. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the design space and control strategy. Product process follows life cycle management approach with continuous improvement. PAT tools are utilized for the online monitoring of the processes. This review paper is dedicated to provide QbD element articulation in product development and its unique applications in the various areas of the product development such as Biotechnology, Nanotechnology products, Nasal products, Inhalation, Injectable products, Targeted drug delivery, complex Solid oral, Transdermal and topical products, Bioavailability and dissolution enhancement, Analytical processes and API manufacturing etc. Current trends in the technical application of the PAT tools are discussed. Keywords: Quality by Design (QbD), Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA) and Design of Experiment (DoE): Product development application of QbD