• Harmonization in Microbial Limit Test of USP and EP

      The harmonized versions have been published and it’s continuing till both the country is ready for harmonization. Japan is also included in harmonization process. The harmonized chapters do not differ in most case from the drafts published in 2003 .This article briefly describes harmonized USP chapters {61} microbial enumeration , {62} absence of specified micro organism, {1111} microbiological attributes to no sterile pharmaceutical product .The format of USP chapters changes drastically with this harmonization whereas the microbial limit tests were two chapters in USP 29(5,6) they are now modified now in modified version to copy the European version. It is most important to the people who want to carry out the tests in both the country and want to export product in both country. The implementation of the tests was in different schedule in US and in Europe. Download
    • WTO Trade Facilitation Agreement & its Status in India

      The World Trade Conference during the BALI summit of 2013 introduced the Trade Facilitation Agreement, in order to reduce the trade related barriers at international borders. Various customs clearance and cross border formalities have become a major barrier in the ease of trade. WTO introduced the TFA with a view to harmonize and rationalize the trade related documentation and procedures for cross border trading. The TFA, which aims to reduce bureaucracy at borders, has the potential to provide a $1-trillion boost to global economy. India has made its stance clear that it will not easily give in to pressure from the Western world over trade protocols of the World Trade Organization, as was also discussed during the talks in Bali in December 2013. India fears that agreeing to the trade facilitation agreement (TFA) could compromise its own food security. In regarding to the same India through discussion and dispute settlement is on the verge of finalizing and signing to this agreement. Currently it is under consideration as up to what extent should India implement the TFA. Various modifications would be required in the EXIM policy of India to implement the TFA. It is forecasted that Indian Pharmaceutical export would experience a rise of 2 folds in Pharmaceutical exports and also would reach to the nations where currently our manufacturers are facing a large amount of Trade related barrier. Thus signing this agreement will not only streamline the imports to our country but will also enhance the globe limits of Indian Pharmaceuticals. Download
    • A Review on Whole Blood Pyrogen Assay

      The whole blood pyrogen test was first described in journal exactly twenty years ago.it employs the cytokine response of blood monocytes for the detection of microbiological contaminates with the potential to finally replace the still broadly used rabbit test. Its measure the fever reaction following injection of the sample to the animals. LAL which is measure the coagulation in a lysate prepared from blood of the horseshoe crab specifically initiated by endotoxins. Pyrogen detection is important in pharmaceutical industry, laboratories and health care institution. As an alternative to the animal consuming rabbit pyrogen test or limulus amoebocytes lysate test, the monocyte activation test was introduced as a gold standard method in European pharmacopoeia. The monocyte activation test has not gained wide acceptance in practice. We stimulate bovine whole blood with different endotoxin preparation (lipopolysaccharide E. coli) as well as the non-endotoxin pyrogen peptidoglycan and lipoteichoic and Prostaglandin E2 (PGE2) served as read out. The test is the first solution enabling adequate pyrogen testing of cell therapies, including blood transfusion, and medical device. As the test can quantitatively assess human relevant airborne pyrogens, the contribution of pyrogens to chronic obstructive lung diseases and childhood asthma can for the first time be defined and home and work place safety improved in the future. Download
    • Formulation and Evaluation of Film Coated Tablet of Rosuvastatin

      Rosuvastatin is an antilipidemic agent that competitively inhibits hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase. Hypo-lipidemic is a disorder of cholesterol level in a liver. Thus formulating Rosuvastatin into a flim coated dosage form would provide fast relief. The tablets were evaluated for the drug content, weight variation, water absorption ratio, wetting time, in vitro disintegration, hardness, friability, thickness uniformity. The tablets disintegrated in vitro within 37 to 40 seconds complete drug were released from tablet within 30 minutes. The results showed that Rosuvastatin Calcium was successfully formulated into a flim coated dosage form. Download
    • Study of Sociodemographic and Morbidity Pattern among Geriatric Population

      Background: This study was carried out to know the sociodemographic and morbidity pattern of geriatric population .As there is increase in the proportion of aged population, there would be increase in the burden of chronic diseases and disabilities in older age group. Thus it was decided to do a cross-sectional study of the geriatric morbidity in a rural population. Method: The detailed information of geriatric population regarding study variables like age, sex, occupation, education and morbidity pattern collected. Predesigned and pretested proforma was used to collect data. Data was analyzed by using suitable statistical method. Result: Among 100 elderly, 56% were men and 44% were women. 41% belonged to age group 61-65yrs. 85% are agricultural workers. Nearly half of them were illiterate. A majority of them had health problems. Most common health problem which were found were arthritis 58%, cataract 42%, URTI and other respiratory problems 36%. Conclusion: It is necessary to put attention over health of geriatric population by community participation. Download
    • Study of Acid Neutralizing Capacity of Various Antacid Formulations

      Background: Antacids are the substances most commonly used by the patients to obtain fast symptomatic relief from dyspepsia. They are the week base which neutralize the gastric acid and raise the pH of the gastric contents. The potency of the antacids depends upon their acid neutralizing capacity (ANC). The antacid neutralizing capacity varies from one another depending upon their formulations. Materials and methods: The present study was undertaken to study the acid neutralizing capacity of commonly available antacids formulations using titration and pH meter method. Six liquid formulations and six solid tablet formulations were studied for their acid neutralizing capacity Results: The acid neutralizing capacity among the liquid formulations was highest for Dioval 26.28±0.05 by pH meter method and 26.17±0.18 by titration method. Among solid antacid formulations ANC was highest with Riflux forte being 25.77±0.06 by pH meter method and 25.73±0.17 by titration method. Both the formulations had higher magnesium hydroxide concentration when compared to other antacids. Conclusion: The acid neutralizing capacity was highest with the antacids containing magnesium hydroxide. For acute fast symptomatic relief from dyspepsia antacids containing higher concentration of magnesium hydroxide would be helpful. Download
    • A Review on Atherosclerosis

      Atherosclerosis is the condition in which deposition of cholesterol on inner linings of arteries take place. In atherosclerosis plaque builds up in a series of stages inside arteries resulting into obstruction to blood flow. Atherosclerosis is the most leading cause of death in industrialized countries. Mostly arteries in the brain, heart, arms, legs & pelvis are affected. The disease is responsible for heart attacks, strokes, aortic aneurysms & peripheral vascular disease. This inflammatory disease is precipitated by elevated levels of low density lipoprotein cholesterol in blood. Endothelial dysfunction is the main stimuli for development of disease. Risk factors of atherosclerosis are both unmodifiable& modifiable which are important in assessment and should be monitored beginning in childhood, even in asymptomatic patients. . The plaques can be predicted by invasive & non-invasive imaging techniques. The blockages are treated by coronary artery bypass, heart catheterization. Medicines along with lifestyle improvement are also useful in management of atherosclerosis. Successful treatment minimizes chances of cardiovascular events, morbidity & mortality. Download
    • Phytonutrients: Add Colors To Diet For Better Health

      Fruits and vegetables are major constituents of our daily diet. They are important sources of carbohydrates, proteins, lipids, vitamins and minerals. Other than these ingredients they also contain bioactive substances called as phytonutrients or phytochemicals. Phytonutrients are also called as phytopigments as they provide color to the fruits and vegetables. The darker the fruit or vegetable,higher would be the Phytonutrients content. They can be classified in to five different color groups Red, Green, White, Orange/Yellow and Purple/ Blue. Unlike vitamins and minerals phytonutrients are not essential to life for development, but they have antioxidant property which protects against cell damage, improves immunity against bacterial and viral infections and decreases the development of chronic conditions such as diabetes, hypertension, cardiovascular diseases. They also have anticancer property which protects against cancers. They are used therapeutically in the treatment of certain medical illness. They do not have adverse effects when compared to allopathic drugs. They are also cost effective and hence reduce the health care cost. It is important to encourage people to consume adequate amount of phytonutrients in their daily diet. Pharmaceutical industries should also try to extract phytonutrients and make it available to people for consumption at reasonable cost .The present article is framed to give information regarding important phytonutrients, their sources and uses. Download
    • Formulation and Evaluation of Transdermal Patches of Duloxetine Hydrochloride

      The rationale of this study was to develop a matrix-type transdermal patches containing drug duloxetine HCl with different concentrations of hydrophobic polymeric systems (Eudragit RL-100 and RS-100) via the solvent evaporation method using 20% w/w of di-n-butyl phthalate (DBT) as plasticizer, 3% concentrations of DMSO used to increase the transdermal permeation of duloxetine HCl. The drug and polymers physicochemical compatibility were studied by means of FTIR and DSC. Formulated transdermal patches were evaluated for thickness, tensile strength, percent elongation, weight variation, drug content, flatness, folding endurance, water vapour transmission rate, percent moisture uptake, percent moisture content, percent swell-ability and ex vivo permeation studies. Ex vivo permeation studies of all preparations were done by Franz diffusion cells on human cadaver skin. From the experimental results obtained, F5 formulation has been selected as the best formulation. The in vitro permeation profiles of all formulations could be best expressed by Higuchi’s equation (R2 = 0.992 to 0.998) for the permeation of drug from a polymeric matrix, indicating the mechanism of drug release from the prepared films to be diffusion controlled. The results suggested that higher the quantity of eudragit RL 100 in the patch, the superior its strength, flexibility, drug release and skin permeation potential. Download
    • Sustained Release Multiparticulate Drug Delivery System of BCS Class I Drug by Extrusion Spheronization Technique

      The objective of the present study is to develop sustained release matrix pellet of Venlafaxine HCl by Extrusion-spheronization. As the drug is BCS Class I i.e. highly water soluble and highly permeable which is formulated to sustained release with HPMC K-100P and ethyl cellulose that deliver sustained release formulation for 24 h. The preliminary formulations are made with different HPMC grades like K-15, K-100P, K-100LV and ethyl cellulose. From preliminary formulations, P1 formulation is chosen for 32 factorial purpose by Design expert software. The F5 factorial formulation has a desired drug release pattern for 24 h. Download
    • Concept of Substantial Similarity In Pharmaceutical Patent Infringement Cases and the Implications of Section 3d of Indian Patent Act

      The research paper discusses the main aspects of Section 3(d) of the Indian Patent Act 1970 with respect to the Indian pharmaceutical industry. Three cases viz. the Novartis Glivec, Pfizer’s Sutent and GSK’s Tykerb have been discussed that explicitly demonstrate, pharmaceutical inventions rarely relate to new chemical entities or novel active ingredients that have never before been available for therapeutic use, thus encouraging pharmaceutical companies to prolong patent protection by obtaining separate patents on multiple attributes of a single product. Section 3(d), whereby, regulates the granting of pharmaceutical product patents by limiting the scope of protection available for derivatives and new uses of a known substance, thereby preventing patents on trivial modifications of known substances. Thus, India’s Section 3(d) should be viewed as a “public health safeguard” that aims to prevent “evergreening,” and not a radical departure from international practices. Download
    • Isothermal and Kinetic Study of the Adsorption of Tetracycline Hydrochloride and Sulphamethoxazole by Bottom Ash and Alkali treated Bottom Ash

      The two forms of Bottom Ash used for the adsorption of Tetracycline Hydrochloride and Sulphamethoxazole are Bottom Ash (BA) activated at 600 °C and activated (at 600 °C) Alkali treated Bottom Ash (ABA). Langmuir isotherm shows greater sorption capacity of ABA for Tetracycline Hydrochloride and Sulphamethoxazole than Bottom Ash. The thermodynamic parameters evaluated show that the adsorption of Tetracycline Hydrochloride on the two adsorbents is endothermic in nature whereas adsorption of Sulphamethoxazole shows exothermic nature. Dubinin Radushkevich isotherm was used to estimate sorption energy. Kinetic studies reveal that the processes in all the cases follow Ho Mckay’s pseudo second order reaction. The studies of mass transfer coefficient for Tetracycline Hydrochloride and Sulphamethoxazole adsorption over ABA was higher than BA which suggests that ion-exchange reaction occurs more on ABA. Download
    • Comparative Efficacy of Chlorhexidine and a Herbal Mouth Rinse in Patients with Gingival Inflammation - A Clinical & Microbiologic Study

      BACKGROUND: Current trends have witnessed a popular inclination towards the use of herbal products in the field of medicine and dentistry mainly because they are naturally occurring and have fewer side effects. Herbal mouthrinses have been recently introduced with the objective of achieving effective plaque control. Till date, chlorhexidine has been a gold standard with regard to anti-plaque agents. The objective of this randomized double blinded controlled pilot study therefore was to assess and compare for the first time, the clinical and microbiological efficacy of chlorhexidine and a herbal mouthrinse in patients with chronic gingival inflammation. MATERIALS & METHODS:- 40 systemically healthy subjects between the age groups of 18-25 yrs with chronic gingival inflammation received oral prophylaxis as part of phase 1 therapy after which they were asked to refrain from oral hygiene measures, and then randomly divided into 2 groups of 20 patients each, one prescribed chlorhexidine and the other, herbal mouthrinse( hiora) twice daily for 2 minutes for four days. On day 5, subgingival plaque samples were collected for culture. Clinical periodontal parameters viz plaque index, gingival index and oral hygiene index were assessed on day 0 and day 5 and analyzed statistically RESULTS There were no statistically significant differences between the two groups with regard to the clinical parameters and colony counts of the bacteria. However, the chlorhexidine group showed statistically suggestive significance with respect to inhibition of S. mutans(p<0.1) and moderate significance with respect to inhibition of A.comitans.(p<0.05) CONCLUSION Herbal mouth rinses may be as effective as chlorhexidine as chemical anti-plaque agents with fewer side effects. However, alternative study designs using larger sample sizes and longer duration are needed to further reiterate its benefits. Download
    • Review on Polymers Used for Film Coating

      Film coating is the process that involves the depositions of a thin, but uniform, film on to the surface of the substrate. Film coating systems are dry blend concentrates of polymers plasticizers, opacifiers, glidantsbinders, anti tacking agents, antifoaming agents, surfactants, fillers and extenders. Film coating systems are ready to use and are available in aqueous or organic systems. They can be reconstituted with organic solvent system, aqueous systems or hydro-alcoholic systems to prepare pharmaceutical solid oral dosage forms. A polymer used for film coating of tablets has great importance. These polymers are described in detail with their characteristics which are responsible for effective, enteric or sustained release action. Polymers are one of the important parts of this type of coating. There are various polymers from different chemical natures are used for film coating; e.g. vinyl polymers, cellulose ethers, polyesters, silicones, polysaccharides and so on. Each one of these polymers has different characteristics and that are useful for thin polymer coating, enteric coating, sustained release action. Among all these properties like solubility or insolubility in aqueous solvent, resistance to gastric fluid, mechanical properties, thermo mechanical properties are useful in preparing a effective form such as thin polymer coating, enteric coating, and so on. Download
    • Are Topical Steroids Useful In Treating Children With Eosinophilic oesophagitis

      Clinical Question Are topical steroids useful in treating children with Eosinophilic oesophagitis? Scenario A fifteen year old known asthmatic girl presents to A&E with recurrent episode of vomiting, history of chest pain and difficulty swallowing foods. She has strong history of atopy and has been prescribed oral aerosolised Fluticasone propionate for treatment of Eosinophilic oesophagitis after attempts of failed exclusion diets. Being a teenager, there was lot of anxiety involved in using oral steroid due to issues with body image, growth impairment and other side effects. You wonder if topical steroid as an alternative is efficacious in treating Eosinophilic oesophagitis. Download