Quality by design is an important tool which used by pharmaceutical manufacturer with increased self-regulated flexibility while maintaining best quality standards and fast production of the product. The concept of QBD was mentioned in the ICH Q8 guidance, which elaborate that “quality cannot be tested into products, i.e., quality should be built in by design”. Under the concept of QbD during designing and development of a product, a company needs to define desire product performance profile [Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA).This paper discuss about the pharmaceutical quality by design and describes how it can be used to study the effect of process parameters on quality attributes of oral dosage forms.

B-Chronic Lymphocytic Leukemia (B-CLL) usually follows an adverse, relentless clinical course by slowly developing drug resistance to fludarabine and other chemo-therapeutic agents, as well as by acquiring new different genetic abnormalities.  As these cells spontaneously produce high amounts of Reactive Oxygen Species (ROS) having an altered redox state in relation to that of normal B lymphocytes, we decided to probe different metal Zinc nanoparticles (ZnNPs), quantifying the levels of Singlet Oxigen (SO) and see if variations of its intracellular concentrations could execute and accelerate deadly programs in leukemic cells when applied with Photodynamic Therapy (PDT), producing almost no significant damage on normal B lymphocytes. In this way, we developed and tested a variety of metal ZnNPs of which one made of 0.5% Manganese Doped Zinc Oxide (MnZnO) was finally selected for further testing as it had the best killing activity in fludarabine resistant B-CLL cells, specially when combined with PDT. An interesting and rapidly dying process of B-CLL cells, known as autophagy, was seen under Transmission Electronic Microscopy (TEM) when incubated with these 0.5% Mn doped ZnO NPs. This phenomenon correlated well with those intracellular increases of SO when PDT was administered, and measured by a novel method first described by us. As this therapy seems to be very specific to fludarabine resistant B-CLL cells, without much harm to normal lymphocytes, it could contribute in the near future as a new innovative targeted strategy to be delivered in the clinical setting, for the definitive benefit of these bad prognostic patients.

The total phenolics, flavonoids and in vitro antioxidant activity of petroleum ether, benzene, ethyl acetate, methanol and ethanol extracts of stem of Drypetes sepiaria were determined using various antioxidant model systems viz, DPPH, hydroxyl, superoxide, ABTS and reducing power. Total phenolic content was estimated by folin-ciocalteau method. Flavonoids were determined by Aluminium chloride method. The total phenolics and flavonoids contents were found to be 0.81 g 100 g-1 and 1.12g 100 g-1 respectively in the methanol extract. Among the solvent tested, methanol and ethanol extracts of D. sepiaria stem showed potent in vitro antioxidant activities. This investigation explored that D. sepiaria stem is a potential source of natural antioxidant.

Berberine Chloride (BC) is an isoquinolinic alkaloid that is extracted from plants of generis Berberis. During the last decade, researchers and clinicians have paid increasing attention to BC, because of its impressive hypoglycemic and blood lipids lowering properties. Several clinical studies gave proof of evidence regarding BC efficacy in humans and pharmacological mechanisms of action, related to the previously mentioned activities, have been proposed and substantially confirmed. On the other side, BC shows a very poor oral bioavailability mainly because of the interaction with P-Glycoprotein (Pg-P) pump, which extrudes BC from inside to outside of the enteric cell. This paper describes a novel oral delivery system containing a Chitosan-N-AcetylCystein salt capable to interact with Pg-P, partially inhibiting BC extruding process. Preliminary data confirming the aforementioned postulated mechanism on Caco-2 in vitro model have been herewith reported and discussed.