A RP-HPLC method was developed and validated for the simultaneous estimation of Metformin Hydrochloride (MET) and Vildagliptin (VIL) in pure and pharmaceutical dosage form. Chromatography was carried on Phenomex (kromosil-250 mm × 4.6 mm, 5 μm) column with mobile phase comprising of phosphate buffer and acetonitrile in the ratio 75:25 v/v. The flow rate was adjusted to 1.0 ml/min with UV detection at 260 nm. The retention times of MET and VIL were found to be 2.4 min, 3.4 min respectively. The different analytical parameters such as accuracy, linearity, precision, robustness, limit of detection (LOD), limit of quantification (LOQ) were determined according to the ICH-Q2B guidelines. The detector response was linear in the range of 25-250 μg/ml, 2.5-25 μg/ml for MET, VIL respectively. The proposed RP-HPLC method is sensitive, precise and accurate so it was successfully applied for the reliable quantification of drugs in the commercial dosage form.

Liposomes are tiny sphere-shaped vesicles, made out of phospholipid bilayersas a cell membrane. Liposomes can be filled with drugs, and used to deliver drugs for several diseases. Among several new drug delivery systems, liposomes serve an advanced technology to deliver active molecules to the site of action. Based on structure, method of preparation, composition and applications liposomes has been classified. There are several methods by which liposomes are prepared. The drugs are loaded in the liposomes by encapsulation, partitioning or reverse loading techniques. Being unique with several advantages liposomes are applied widely in the field of medicine for safe delivery of drugs. This paper summarizes the various advantages, mechanisms, methods of preparation and applications of liposomal preparations.

Plants are the important sources of newly derived drugs for the treatment of various diseases in India. The present study was focused the qualitative investigation of Vetiveria lawsonii. The methanol extract was prepared by Soxhlet extraction and the qualitative investigation revealed the presence of Flavonoids, Terpenoids, Saponins, Phytosterols, Proteins, Steroids and Anthocyanins. The Agar well diffusion method showed that the methanol extract of Vetiveria lawsonii having high Antimicrobial activity against the microbes. Hence, we can conclude that the methanol extracts of Vetiveria lawsonii was possess Antimicrobial activity.

In this study dental films were formulated with ofloxacin which are used in treatment of periodontits. Hydroxy Propyl Methyl Cellulose (HPMC) of grade k100 is used as a polymer. Polyvinyl alcohol is used as an excipient. Ofloxacin dental films are formulated by solvent casting method. Various evaluation tests like weight variation, moisture content, thickness, folding endurance, drug content and in-vitro drug release were performed for formulations. Formulation F2 shows good release of 97.2%. The dental films are kept in intrapocket region that is region between tooth and gum where the infection is at peak levels. The release of drug reduces the inflammation, pain due to infection.

The study was design, formulation and evaluation of oral sustained release tablets of Lamivudine Hydrochlorideusing different natural polymers such as Chitosan, Guar gum and Xanthan gum. The Lamivudine Hydrochloride oral sustained release tablets were prepared by using wet granulation method. The formulated different ratio of oral sustained release tablets of Lamivudine were evaluated by different parameters. The prepared granules were evaluated for angle of repose, bulk density, tapped density, compressibility index and hausner’s ratio. The tablets were evaluated to thickness, weight variation test, hardness, friability, drug content, in vitro release and kinetic release studies. The results conclude that FL-7 can be considered as a optimized formula for sustained release of drug for 24 hours. Kinetic treatment to thein vitro release data revealed that the drug release followed first order, non - fickian diffusion, It means the release of drug from tablet diffusion mechanisms are used.

The regulatory process to obtain marketing authorisations (MAs) for drugs in Latin American (LATAM) countries, despite regional harmonisation efforts, is highly country-specific. Complex and evolving ad-hoc requests from reviewers must be proactively addressed to avoid costly delays or show-stoppers to local product launches. This article offers a pharmaceutical regulatory environment in LATAM, resulting from more than a decade of experience in a biotech company, to ensure successful global regulatory strategy. The quality, safety and efficacy data has its own importance in the registration dossier. The commercial significance of markets is increasing globally. It is vital for pharmaceutical industry to cope with the regulatoryrequirements for betterment of public and to ensure their place in the market. Although the International Conference on Harmonisation (ICH) Common Technical Document (CTD) can serve as a resource for most local MA applications, it is not necessarily required in its full length. Additionally, a significant amount of mandatory and highly country-specific documentation (related to infrastructure, legal documents, stability studies, labelling, etc) require strategic planning and allocation for successful and timely local approvals. Exhaustive identification of actual requirements can present challenges due to frequent changes in regulations, unclear expectations, etc. Having as much early visibility and command of the LATAM country-specific requirements and health authorities’ (HAs) expectations will help the pharmaceutical industry to improve planning for global MA applications, optimally manage internal expectations, and most importantly give patients in the regionfaster access to therapies and better quality of life.

A simple, precise, accurate and rapid reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of Rabeprazole and Diclofenac in pure and tablet dosage form. The method was carried out in isocratic using mobile phase, water and acetonitrile (50:50)and Phenomenex C-18 column having i.d of 240×4.6 mm and 5µm particle size was used. Flow rate was adjusted to 1.0 ml/min and effluents were monitored at 278 nm. The retention time obtained for Rabeprazole and Diclofenac was 2.6 and 3.7 min respectively. The calibration curves were linear in the concentration range of 5-30 µg/ml for Rabeprazole and Diclofenac 25-150µg/ml for. The developed method was validated in accordance to ICH guidelines.

Varicosities of the veins in the anal canal are known as haemorrhoids. The perverted activities such as sedentary life style, western dietary habits, strange sleep habits which plays as important role to bring out this disease. In siddha system, lot of herbal and herbominaral drugs were prescribed for haemorrhoids. Atthi Pinchu Ennai (APE) is one of the poly herbal formulation quoted in ‘Brhamamuni Vaithiya Soothiram 390’ indication for Rattha Moolam (Haemorrhoids). The present study aims to carry out acute and sub acute toxicity of APE. Adult both sexes of Wister rats weighing 150-200 gm (8 -12 weeks) were used. For acute studies different doses of APE were administer orally to rats once daily for one week as per Organization for Economic Cooperation Development (OECD)  423. In sub acute toxicity study was carried out OECD 407 for 28 days in different doses as 315mg/kg, 1575mg/kg. and 3150 mg/kg body weight. Haematological, biochemical parameter, histopathological studies were performed for all animals. The study conclude that on oral administration of 3150 mg/kg body weight of APE to wister rats there was no change in behaviors movements and no characteristic clinical sign of toxicity and no mortality was observed

Valsartan  is  a  BCS  class  II  antihypertensive  drug  whose bio availability  is  dissolution  rate  limited. Various capsule formulations of valsartan were prepared using croscarmellose sodium and sodium lauryl sulfate.  Their dissolution profiles were compared with commercial marketed formulations.  FormulationJ was found to have similar t90   values to marketed brands statistically. Influence  of  sodium  lauryl  sulfate  on the  solubility  of  valsartan  was studied  and  was  found  to  increase  with  the  concentration  of  sodium lauryl  sulfate. Compatibility  of  valsartan  with croscarmellose sodium and  sodium  lauryl  sulfate  was  studied  by  non-thermal methods like HPLC and IR.

It seems biological medicines are set to play a major part in the pharmaceutical industry’s future and they already play a major part in its current growth. At the moment, biologicals account for 10 -15% of the pharmaceutical market. More than one-fifth of new medicines launched on the world market each year are now biotechnology derived. The objective of this article is to facilitate regulatory requirements for the approval process of Biosimilars and the need for Biosimilar product class-specific guidelines in Regulated and emerging markets. Biosimilars are biological products that are the replicas of their innovator biopharmaceuticals. Specified regulations, and approval process of generic version of biologicals exists depending on the country. Each class of biologic varies in its benefit / risk profile, the nature and frequency of adverse events, the breadth of clinical indications, and whether surrogate markers for efficacy are available and validated. But most of the countries do not have specific guidelines for potential market biological products like monoclonal antibodies (mAbs), interferon beta and insulin.