About Author: R. C. PATEL, C. K. BHUVA, MR. R. P. SINGH, MR. ABHISHEK DADHICH, MR. ANIL SHARMA.
Department of Quality Assurance, Gyan Vihar School of pharmacy,
Suresh Gyan Vihar University,
Jaipur, Rajasthan, India-302025

Reference ID: PHARMATUTOR-ART-1053

Abstract
Validation has become one of the pharmaceutical industry’s most recognized and discussed subjects. It is a critical success factor in product approval and ongoing commercialization. This article provide brief introduction about the pharmaceutical process validation and its importance according to regulatory provision, also provide the answer of question like why to do, when to do and how to do it. This work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process. Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.

Biorad Medisys Pvt. Ltd. is an Indian company providing the world with innovative life saving medical devices in the field of Urology, Gastro-enterology, Interventional Radiology and Gynecology. Our organization is committed to satisfying our customer's world wide with quality, cost effective products.

MicroGene has been driven by a clear objective: to bring in medical technology to help people live healthier lives. This objective drives our work. It’s a  commitment to focusing on what matters most: life and the potential it holds when we are feeling our best.

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

About Author: Deepali Jaybhaye, Sushilkumar Varma, Amol Gite
Department of Pharmacology, Mahatma Gandhi Mission Hospital,
Aurangabad, Maharashtra – 431001, India.
Vijay Bonde
Department of Pharmacology, Mahatma Gandhi Institute of Medical Sciences,
Sewagram, Wardha, Maharashtra – 402102, India.

Reference ID: PHARMATUTOR-ART-1052

Abstract
Tectona Grandis linn. is one of the well known Indian herbs. In Ayurveda Tectona grandis stem extract has tocolytic effect. The main syndrome of preterm birth is caused by uterus contractions from excitatory factors. Administration of tocolytic agents is a strategy to prevent the occurrence of preterm births. The aim of this study was to investigate the effects of Tectona grandis stem extract on the contractions of uterine strips isolated from non?pregnant female Wistar rats (250~350 g) prior injected (Before 24 Hrs) Estradiol benzoate. Contractions of the uterus were induced with Oxytocin 0.01 IU. The results compared with stander drugs like Magnesium Sulfate (75 mg), Nifedipine (0.18 mg), and Isoxsuprine (0.18 mg) along with their effect on frog blood vessels, rat and frog heart, skeletal muscle. After seeing these effects we conclude that Tectona grandis stem extract possess the same tocolytic effect as that of standard drugs.

About Author: Imran A. Kayyum. Tadwee1*, Sadhana Shahi1, Mahesh Thube1
Government College of Pharmacy,
Aurangabad, Maharashtra, India

Reference ID: PHARMATUTOR-ART-1051

Abstract
The object of this work is to formulate & observe the effect of HPMC K15 polymer on various parameters of evaluation of carbamazepine nasal mucoadhesive microspheres. The microspheres are prepared by spray drying technique with different formulation composition of HPMC K15. The microspheres obtained are meant for the evaluation for its production yield, particle size, swelling ability, Drug content, encapsulation efficiency and Invitro drug release study. IR, TLC study is performed for drug Polymer interaction study of the optimized batch. Morphology is studied be SEM. The results obtain shows that the release rate of the drug decreases and particle size, production yield, swelling index, encapsulation efficiency, mucoadhesion is increases with increase in drug: polymer ratio. TLC study shows no interaction of Carbamazepine and HPMC. SEM study reveals the encapsulation of drug in the HPMC K15 Polymer. The data obtained after Invitro release study fitted to PCP disso software for mechanism of release & kinetic model. The data also treated with design expert software v 7.1 it shows the model is significant. Overall it shows that the polymer HPMC does not posses any interaction with the carbamazepine and showing controlled drug release behavior.

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Shield Healthcare is today a recognized, integrated pharmaceutical company with core competencies in the development and manufacture of Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms as well as in drug discovery.

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Post: Executive, Officer-Dispensing, Officer/Sr. Officer-QC

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About Author: 1. Shah Dhaval D., M.Pharm-II Semester, Quality Assurance Department, Gyan Vihar School of Pharmacy, Jaipur, India
2. Sharma Anil, M.Pharm, H.O.D. Quality Assurance Department, Gyan Vihar School of Pharmacy, Jaipur, India

Reference ID: PHARMATUTOR-ART-1050

Abstract
Generic pharmaceutical products need to confirm to the same standard of quality, efficacy and safety as required of the originator’s (innovator) product. Spefically, the generic product should be therapeutically equivalent and interchangable with the reference product. Testing the bioequivalence between a test product pharmacetically equivalent or a pharmaceutical alternative and a suitable reference product in a pharmacokinetic study with a limited no of subjects is one way of demonstrating therapeutic equivalence. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical and clinical data to establish safety and effectiveness. This article provides the information about important aspect involved in bioequivalence and regulatory requirment for bioequivalence study.

GPAT-2011 PAPER

{Answers are on the end page of question Paper}

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

About Authors: Biswajit Panda^1*, Abhinav Raoot¹, Vaishali Kilor¹, Nidhi Sapkal²
Dept of Pharmaceutics¹ and Dept of Pharmaceutical Chemistry²
Gurunanak College of Pharmacy, Nagpur

Reference ID: PHARMATUTOR-ART-1049

Abstract
Excipients are all substances contained in a dosage form other than the active substance. Tablets are the most commonly used dosage form because of the ease of manufacturing, convenience in administration, accurate dosing and stability compared to oral liquids and direct compression is the preferred method for the preparation of tablets because of several advantages. In order to justify the high rise in new drug development and high industrial output demand, new excipients with purpose satisfying characteristics are the need of the hour.New combinations of existing excipients are an interesting option for improving excipient functionality now-a-days. The current review article is prepared to have a look over the recent development in excipient technology and the approaches involved in development of such excipients. It signifies the synergistic outcome of the combination of excipients taking their material property into consideration. It also emphasises on the particular material properties in terms of physic-mechanical that are useful to overcome the limitation of existing excipients. All the developed co-processed excipients are enlisted highlighting their multi-functional and beneficial characteristics. Regulatory issues concerned with the development of new excipient are also discussed.

About Authors: Mrugank BP¹,  Mangala L²,  Hareesha RP³
Department(s) and institution(s)
1. National Institute of Pharmaceutical Education and Research (NIPER), Department of Pharmacy Practice, M.Pharm (Student)
2. Gauhati Medical College and Hospital (GMCH), Department of Pharmacology, Prof and Head; Chief academic co-ordinator, NIPER-Ghy.
3. National Institute of Pharmaceutical Education and Research (NIPER), Department of Pharmacy Practice, M.Pharm (Student)

Reference ID: PHARMATUTOR-ART-1048

Abstract:
Background: "Pharmacovigilance is the science and activity relating the detection, assessment, understanding and prevention of adverse effects or any other possible drug - related problems." ^[1]

Literature:Periodic safety update reports (PSUR)^[2]and Medical Dictionary for Regulatory Activities (MedDRA)^[3]are two important assets for maintenance of Drug safety Pharmacovigilancesystem as they are designed to represent the safety data on a particular drug from all the sources and geographical regions in the worldand to understand internationally, accepted clinically validated medical terminology for medical coding respectively.