PHARMACEUTICAL EXCIPIENTS: GLOBAL REGULATORYISSUES

An excipient may be defined as an ingredient that is intentionally added to a drug for purposes other than the therapeutic or diagnostic effect at the intended dosage. Excipients have functional roles in pharmaceutical dosage forms which include the suitable form of consistency, modulating solubility and bioavailability of active ingredients, enhancing stability of the active ingredients in finished dosage form and many others. In most of the developed countries, the excipients are regulated as an active pharmaceutical ingredient. In Europe, it is assumed that novel excipients need to be evaluated as new chemical entities. In United State, the Food and Drug Administration assesses and permits use excipients as part of new drug application. The lack of harmonized international regulatory guidelines leads to the formation of the International Pharmaceutical Excipients Council (IPEC) in 1991. The IPEC was found to calibrate with different countries like Japan, Europe and China to address prevalent industry concerns related to the international harmonization of excipients standards, the introduction of useful new excipients to market place, and development of safety evaluation guidelines for the excipients. In the present study, an attempt has been made to investigate global issues governing regulations of pharmaceutical excipients.Key words: pharmaceutical excipient, regulatory guidelines, IPE

Panoramic View on Quality by Design

Quality by design (QbD) is an essential tool in pharmaceutical environment for having product/process/method impregnated with quality. Now, QbD is the greatest solution to construct quality in all pharmaceutical products, while in the same time making it as a part of system is also a key challenge for Industry. For understanding of QbD, it is very much essential to understand the desire product performance profile [Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA). Basically, for meeting the product attributes, the product formulation and process can be designed on the basis of these stated parameters. Nonetheless, this helps in recognizing the effect of raw materials, critical material attributes (CMA), critical process parameters (CPP) on the CQAs and identification and control sources of variability. The in and out understanding for QbD in generic pharmaceutical industry is really vital, because now and then FDA is taking firm stand to make mandatory “deadline” for inclusion of QbD. Therefore, an attempt has been made to highlight quality by design for generic drugs and its implications to pharmaceutical industry

Cosmetics: Regulatory Scenario in USA, EU and India

The efficacy, safety, regulatory framework, and marketing of cosmetic products are the most important factors for the growth of the cosmetic industry. The safety of cosmetic goods is regulated by diverse regulatory bodies around the globe who all have their own rules and regulations. The regulations of cosmetics like, nomenclature, labeling, and safety of colorants(s) alter in different countries. Much stringent legislation exists in the European Union (EU) and The United States of America (USA) has very much stringent legislation in order to regulate the use of cosmetic products. The safety assessments of cosmetic products are affected by the different regulations of different regulatory bodies. Nevertheless, there is a need for harmonized regulations throughout the world. An attempt has been made in the present manuscript to compare the current regulatory scenario of cosmetics in the USA, EU, and India.   Most web searchable keywords  cosmetics regulation in India pdf, the definition of cosmetics as per Indian regulations, the definition of cosmetics as per Indian and EU regulations, cosmetic labeling requirements India, labeling requirements for cosmetics in India, cosmetic regulation in India, European fulfillment for cosmetics, the definition of cosmetics as per Indian regulation, the international nomenclature of cosmetic ingredients Slideshare, Indian cosmetic sector analysis 2011,&nbsp

Models for the Prediction of Receptor Tyrosine Kinase Inhibitory Activity of Substituted 3-Aminoindazole Analogues

The inhibition of tumor angiogenesis has become a compelling approach in the development of anticancer drugs. In the present study, topological models were developed through decision tree and moving average analysis using a data set comprising 42 analogues of 3-aminoindazoles. A total of 22 descriptors (distance based, adjacency based, pendenticity and distance-cum-adjacency based) were used. The values of all 22 topological indices for each analogue in the dataset were computed using an in-house computer program. A decision tree was constructed for the receptor tyrosine kinase KDR (kinase insert domain receptor) inhibitory activity to determine the importance of topological indices. The decision tree learned the information from the input data with an accuracy of 88%. Three independent topological models were also developed for prediction of receptor tyrosine kinase inhibitory (KDR) activity using moving average analysis. The models developed were also found to be sensitive towards the prediction of other receptor tyrosine kinases i.e. FLT3 (fms-like tyrosine kinase-3) and cKIT inhibitory activity. The accuracy of classification of single index based models using moving average analysis was found to be 88%. The performance of models was assessed by calculating precision, sensitivity, overall accuracy and Mathew’s correlation coefficient (MCC). The significance of the models was also assessed by intercorrelation analysis

Permeability Evaluation Through Chitosan Membranes Using Taguchi Design

In the present study, chitosan membranes capable of imitating permeation characteristics of diclofenac diethylamine across animal skin were prepared using cast drying method. The effect of concentration of chitosan, concentration of cross-linking agent (NaTPP), crosslinking time was studied using Taguchi design. Taguchi design ranked concentration of chitosan as the most important factor influencing the permeation parameters of diclofenac diethylamine. The flux of the diclofenac diethylamine solution through optimized chitosan membrane (T9) was found to be comparable to that obtained across rat skin. The mathematical model developed using multilinear regression analysis can be used to formulate chitosan membranes that can mimic the desired permeation characteristics. The developed chitosan membranes can be utilized as a substitute to animal skin for in vitro permeation studies

THERAPIES IN CANCER TREATMENT: AN OVERVIEW

Cancer is one of the most frequent and distressing diseases. The mortality caused by cancer and its prevalence has increased during the last 50 years. Cancer is still one of the most destructive disease of human beings due to its complexity and progressive nature and the clinical management of this deadly disease continue to be a challenge for the 21stcentury. Various types of cancer are reported in literature such as Carcinoma, Sarcoma, Lymphoma, leukemia, Blastoma and Germ cell tumor. There is a continuous need for new and better cancer therapies. A few years ago, surgery and radiotherapy were the only effective way to fight tumor growth. Now various therapies for the treatment of cancer have been developed including chemotherapy, radiation therapy, proton therapy, thermotherapy, Photodynamic therapy, laser therapy, sentinel lymph node biopsy, cryotherapy and differentiation therapy. These therapies have dramatically changed the scenario of cancer treatment. Further research is also needed to discriminate the various genes and signaling pathways in the process of the carcinogenesis of cancer stem cells for the development of novel therapies, with the ultimate goal of eliminating the residual disease and recurrence. This review aims to present the various types, stages of cancer and also focus on various therapies used for the treatment of cancer.Â

Models for Antitubercular Activity of 5′-O-[(N-Acyl)sulfamoyl]adenosines

The relationship between topological indices and antitubercular activity of 5′-O-[(N-Acyl)sulfamoyl]adenosines has been investigated. A data set consisting of 31 analogues of 5′-O-[(N-Acyl)sulfamoyl]adenosines was selected for the present study. The values of numerous topostructural and topochemical indices for each of 31 differently substituted analogues of the data set were computed using an in-house computer program. Resulting data was analyzed and suitable models were developed through decision tree, random forest and moving average analysis (MAA). The goodness of the models was assessed by calculating overall accuracy of prediction, sensitivity, specificity and Mathews correlation coefficient. Pendentic eccentricity index – a novel highly discriminating, non-correlating pendenticity based topochemical descriptor – was also conceptualized and successfully utilized for the development of a model for antitubercular activity of 5′-O-[(N-Acyl)sulfamoyl]adenosines. The proposed index exhibited not only high sensitivity towards both the presence as well as relative position(s) of pendent/heteroatom(s) but also led to significant reduction in degeneracy. Random forest correctly classified the analogues into active and inactive with an accuracy of 67.74%. A decision tree was also employed for determining the importance of molecular descriptors. The decision tree learned the information from the input data with an accuracy of 100% and correctly predicted the cross-validated (10 fold) data with accuracy up to 77.4%. Statistical significance of proposed models was also investigated using intercorrelation analysis. Accuracy of prediction of proposed MAA models ranged from 90.4 to 91.6%

Effects of Curcumin-loaded PLGA Nanoparticles in MDA-MB231 Human Breast Cancer Cells

Aim: This study was aimed at evaluating the anticancer potential of curcumin-loaded poly(lactic-co-glycolic acid) (PLGA) based nanoparticles (NPs) in MDA-MB231 human breast cancer cells. Methods: Curcumin-loaded PLGA NPs were developed using a modified solvent evaporation technique. Physical characterization was performed on the formulated NPs. Furthermore, in vitro experiments were conducted to study the biological activity of the curcumin-loaded NPs. Results: Curcumin-loaded PLGA NPs demonstrated high encapsulation efficiency and sustained payload release. Moreover, the NPs exhibited a significant reduction in cell viability, cell migration and cell invasion in the MDA-MB231 cells. Conclusion: The study revealed that the formulated curcumin-loaded PLGA NPs possessed significant anti-metastatic properties. The findings showcased the possible potential of curcumin-loaded NPs in the management of debilitating conditions such as cancer. In addition, this study could form the basis for further research and advancements in this area. </jats:p

Nanocarriers: more than tour de force for thymoquinone

Introduction: Thymoquinone (TQ), 2-isopropyl-5-methylbenzo-1, 4-quinone, the main active constituent of Nigella sativa (NS) plant, has been proven to be of great therapeutic aid in various in vitro and in vivo conditions. Despite the promising therapeutic activities of TQ, this molecule is not yet in the clinical trials, restricted by its poor biopharmaceutical properties including photo-instability.Area covered: This review compiles the different types of polymeric and lipidic nanocarriers (NCs), encapsulating TQ for their improved oral bioavailability, and augmented in vitro and in vivo efficacy, evidenced on various pathologies. Furthermore, we provide a comprehensive overview of TQ in relation to its encapsulation approaches advancing the delivery and improving the efficacy of TQ.Expert opinion: TQ was first identified in the essential oil of Nigella sativa L. black seed. TQ has not been used in formulations because it is a highly hydrophobic drug having poor aqueous solubility. To deal with the poor physicochemical problems associated with TQ, various NCs encapsulating TQ have been tried in the past. Nevertheless, these NCs could be impending in bringing forth this potential molecule to clinical reality. This will also be beneficial for a large research community including pharmaceutical & biological sciences and translational researchers