Ravi

The present study deals with the elaborated overview of comparative study of in-process and finished product quality control tests for parenteral products taking compendia specifications of Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) into consideration. When it comes to most sensitive parts of body i.e.; veins, a high degree of precautions should be taken during and after production of product for it to avoid any hitches. The sterility of these parenteral products, as well as accuracy in the calculation and preparation of doses is of great importance and a must in terms of compliance. The high graded quality product always refers to a product which is within the compendia limits. This article focuses on the comparison of Pharmacopoeial specifications of parenteral preparations, the procedures that are employed to maintain the quality and sterility of these ophthalmic products. This covers specifications and limits of different dosage forms according to different Pharmacopeia (like IP, BP, USP, JP etc.) which helps in comparative study of specifications provided in different Pharmacopeia as well as highlighting the differences in standards and also focussing on the specifications of different nations. Different regulatory requirements of the respective countries demand products with different specific limits so this comparative study will help in meeting all the requirements of all the pharmacopoeias and later the regulatory requirements of that particular country.

Surrogacy is an arrangement in which a woman carries a pregnancy and gives birth to a baby for another woman. Surrogate motherhood is one of many currently available forms of Assisted Reproductive Technologies (ARTs) that have developed in response to the increasing number of individuals/couples who find themselves unable to conceive a child on their own. The main aim of this study is to give an overview of legal aspect of surrogate mother. Surrogacy is gaining popularity as this may be the only method for a couple to have their own child and also because adoption process may be long. India is leading in this business because of the easy availability of surrogates at comparatively less cost. Many agencies have come forward with the intention of outsourcing pregnancy to foreign countries. In India this process had been regulated by the law from 2002. Though the regulation have been initiated, they are not so stringent when compare to other countries hence many foreigners are coming to India for surrogate mother. It may be concluded that Assisted Reproductive Technology (ART) Bill 2010 has provided for single parenthood by allowing “unmarried couples” and “single persons” from India and abroad to have children using ART procedure and surrogate mothers in India.

The methanolic extract of Alstonia scholaris (L) R.Br. stem bark was screened for hepatoprotective activity against Swiss albino rats with liver damage induced by carbon tetrachloride. The results of hepatoprotective activity revealed that the methanolic extract of Alstonia scholaris significantly decreased the biochemical parameters (SGOT, SGPT, ALP, TP and TB). Silymarin (25 mg/kg), a known hepatoprotective drug, was used for comparison. The extract did not show any mortality up to a dose of 2000 mg/kg body weight. The findings indicated that the methanolic stem bark extract of Alstonia scholaris (L.) R.Br. (200 mg/kg) was effective in bringing the functional improvement of hepatocytes. The hepatoprotective activity was also supported by histopathological studies of liver tissues. Key words:  Alstonia scholaris, extract, hepatoprotective, carbon tetrachloride.

Conventional drug therapy requires periodic doses of therapeutic agents. These agents are formulated to produce maximum stability, activity and bioavailability.  Floating drug delivery systems (FDDS) have a bulk density less than gastric fluids and so remain buoyant in the stomach without affecting gastric emptying rate for a prolonged period of time. While the system is floating on the gastric contents drug is released slowly at the desired rate from the system. The present study mainly focuses on the development and evaluation effervescent based floating matrix tablet of famotidine. This oral drug delivery offers several advantages over the standard conventional oral dosage forms. Effervescent based floating matrix tablet of famotidine was prepared using sodium bicarbonate as effervescent agent and by incorporating hydrophobic agent stearic acid which retards the drug release and allow the dosage form to float on gastric fluid for several hrs. Then the tablet was evaluated for hardness, friability, drug content and in vitro drug release. On the basis of the preliminary trials, a 32 full factorial design was employed to study the effect of independent variables, HPMC K4M: Carbopol 934P ratio (X1) and concentration of effervescent agent (X2) on dependent variables like floating lag time, Q4 and Q8. The best batch (F3) exhibited optimum floating lag time (16 sec), drug content (98.94%), Q4 (54.36 %), Q8 (93.98%) and similarity factor (83.92). The controlled release of famotidine was observed and good fit to the zero order was demonstrated.

Lignocaine Hydrochloride (LH) is a local anesthetic agent used in the treatment of periodontal and various other dental diseases. It undergoes extensive first pass metabolism with a consequent low bioavailability. Keeping this into account the research work was focused to formulate buccal tablets of LH in an effort to achieve prolonged relief from pain. Buccal tablets were prepared by direct compression method using different bio-adhesive polymers such as chitosan with methocel K15, sodium alginate and methocel K4. Ethyl cellulose (EC) was used as an impermeable backing layer. The optimized formula (F9) was evaluated for in vitro drug release (99.51%±0.59) in phosphate buffer for 6 hrs and bio adhesion strength was found to be 22 gr. The amount of drug permeated through the buccal membrane was found to be 85.03 ±0.21.Stability studies of the F9 indicated no significant changes with respect to drug content, in-vitro release and ex-vivo permeation. Key Words: Lignocaine hydrochloride, Buccal drug delivery system, First pass hepatic metabolism, Ex vivo permeation studies.

Biomarkers and surrogate endpoint largely replaced the clinical trials which are needed to be carried out before drug approval in regular approval process under FDA (Food and Drug Administration), a governing pharma regulatory body in USA and as a result approval process can be accelerated. It can be said that surrogate endpoint and biomarker are substituting the clinical trials and decrease the duration of product development phase as well as decrease the entry time period of novel products in the market. The article enlightens the extent to which the biomarkers and surrogate endpoint have benefited the pharma industry for expediting the entry of their products into the market at the earliest to get the maximum benefit of the product during the patent period. Simultaneously article also throws light on the history of risk factors of surrogate endpoint which are likely to jeopardize the interest of the human beings involved. It may conclude that Biomarkers and surrogate endpoints play pivotal role in accelerating approval process for drug approval in USA and the usage of these parameters to minimize the casualty of human lives who are suffering from serious life threatening diseases by providing recent research products which have caliber to cure or improving the quality of life. Key words: Clinical trial, Biomarker, Surrogate end point, Accelerated approval, Caliber to cure, Casualty of human lives.

  Liver plays a major role in detoxification. Any injury to it or impairment of its function may lead to many implications on one’s health. Management of liver diseases is still a challenge to modern medicine. The allopathic medicine has little to offer for the alleviation of hepatic ailments whereas the most important representatives are of phytoconstituents. The work presented in this paper is on plant mentioned as Kayakarpam plants in published as well as unpublished palm leaf literatures. The study was aimed to evaluation of the hepatoprotective activity of the whole plant Sida cordata on the Chang cell line (normal human liver cells). The ethanolic extract was tested for its inhibitory effect on chang cell Line. The percentage viability of the cell line was carried out. The cytotoxicity of Sida cordata on normal human liver cell was evaluated by the SRB assay [Sulphorhodamine B assay] and MTT assay [(3-(4, 5 dimethylthiazole –2 yl)-2, 5 diphenyl tetrazolium bromide) assay]. The principle involved is the cleavage of tetrazolium salt MTT into a blue coloured derivative by living cells which contains mitochondrial enzyme succinate dehydrogenase However, the information available on the pharmacological activity of the plant is very limited. Hence, it was proposed to carry out a preliminary in vitro analysis of the hepato protective activity of the plant, which gave promising results.