Quality by Design: Concept to Applications.

BACKGROUND: Quality by Design (QbD) is associated with a modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also lead to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify the desired and required product performance report, such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA). METHODS: This review highlighted the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected thus, consistently manufacturing the required product. Risk assessment tools and design of experiments are its prime components. RESULTS: This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. CONCLUSION: This article provides a complete data as well as the roadmap for universal implementation and application of QbD for pharmaceutical products.

Ex vivo Antispasmodic Activity of Aqueous Extract of Flowers of Muntingia calabura Linn. on Excised Rabbit's Jejunum.

OBJECTIVE: The present study has been undertaken with the main objective of evaluating the aqueous extract of flowers of Muntingia calabura for antispasmodic activity on isolated rabbit's jejunum. MATERIALS AND METHODS: The study was carried out on isolated rabbit's jejunum preparations. The aqueous extract of flowers of M. calabura was applied in different doses by cumulative manner without washing the tissue. Spontaneous contractions abolished by the extract were recorded. RESULTS: In isolated rabbit's jejunum preparation, the flower extract of M. calabura inhibited the spontaneous contractions in a concentration-dependent manner with IC100 value of 36 ± 3.02 µg/mL, which is potent than the standard drug verapamil with IC100 value of 40 ± 1.02 µg/mL on the rabbit's jejunum. CONCLUSION: The aqueous extract of flowers of M. calabura exhibits significant dose-dependent relaxations of spontaneous contractions in isolated rabbit's jejunum preparations. SUMMARY: Flowers of Muntingia calabura L. were collected, authenticated and extracted by water using soxhlet apparatus. Crude extract was qualitatively tested for the presence of phytochemical constituents and it shows the presence of flavonoids, carbohydrates, glycosides, saponins, and phenolic compounds. Crude extract was quantitatively tested for its antispasmodic potential. It showed a dose-dependent relaxation of spontaneous contractions in isolated rabbit's jejunum preparations and it was concluded that the aqueous flower extract of Muntingia calabura L. has potent antispasmodic activity. Abbreviations Used: IC100: Maximal inhibitory concentration, IAEC: Institutional animal ethics committee, SIMS: Southern institute of medical sciences, h: Hour, kg: Kilogram, µg: Microgram, mL: Milliliter, mM: Millimol, °C: Degree Celsius.

Nanoparticles for Cancer Targeting: Current and Future Directions.

The targeting of pharmaceuticals is a rapidly evolving strategy to overcome the difficulties in therapeutic delivery, especially to the tumor site. Unlike traditional drug delivery systems, nanoparticles based compounds attain superior accretion in the tumor site by their active or passive mechanisms. Due to their exclusive properties like small size, large surface-to-volume ratio, tunable surface chemistry, and the ability to encapsulate various drugs, the nano-sized carriers provide longer circulation time; easy penetration into cellular membranes; efficient site-specific targeting. Recent advancements in polymeric- nanomedicines involve targeting of polymer-based nanoparticles (NPs), micelles, polyplexes, dendrimers, polymersomes, drug/protein conjugates and lipid hybrid systems to tumor pathological site. With different functional moieties, NPs improve the performance in terms of targetability, circulation longevity, enhanced intracellular penetration, stimuli-sensitivity, and carrier-mediated visualization. This review highlighted different preparative techniques and types of nanoparticles in the most recent developments in cancer treatment including promising opportunities in targeted; combination therapy; and other medical and biomedical applications. Various delivery strategies and future prospects of nanoparticles are also enlisted. Apart from that, the review discusses the potential advances and targeting of polymeric nanocarriers within the scope of cancer therapeutic system to emphasize it as an auxiliary tool to the customary drug delivery systems.