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REGULATORY AFFAIR: LINK BETWEEN COMPANY AND GOVERNMENT AUTHORITY

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About Author:
Yogeshkumar B. Viradiya
Department of Regulatory Affairs, Institute of Management Sciences and Research (IMSR),
Nagpur, Maharashtra.  
viradiya2210@gmail.com

Abstract:
Regulatory affair is the very important department in Pharmaceutical Company. For the protection of public health, government of various countries have developed the regulation for pharmaceutical, cosmetic product, pesticides, veterinary medicines, medical device, agrochemical and complementary medicines by controlling the safety and efficacy of product. Regulatory affair department prepare the registration document which submits to the regulatory agency of various countries for approval of new drug which contain the all important information about new drug. It is called the drug master file of Common technical document (CTD). Regulatory affair is the link between company and government authority. Regulatory affair is important for Product management, Clinical trial, Research & Development. Regulatory personnel have to maintain contact with other specialist like chemist, doctors, veterinarians, engineers, pharmacologist, toxicologist, pharmacists, and accountant. Regulatory authorities of different countries prepare their separate rules and regulation. Main aim of regulatory affair department is to provide safe and effective medicine to people of different companies. Separate rules and regulation in different countries which must be followed by all pharmaceutical company in all over the world.


LIQUISOLID TECHNOLOGY: AN EMERGING AND ADVANCE TECHNIQUE FOR ENHANCING SOLUBILIZATION

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ABOUT AUTHORS:
Imran khan*, M. Idreesh khan, Unis khan
Dept. of Pharmaceutics in Shri Ram College of pharmacy, Banmore, Morena,
Madhya Pradesh, India
khan.imran731@gmail.com

ABSTRACT:
This is the novel approach for enhancing dissolution and bioavailability of BCS-II class drugs. Solubility is the major problem in the development of pharmaceutical dosage forms. Liquisolid technique is the novel and promising technique to overcome these problems. The liquisolid systems are to improve the dissolution properties of water insoluble agents. For enhancing the dissolution rates for water insoluble drugs we used carrier and coating materials like microcrystalline cellulose (Avicel), silica (Aerosil), sodium starch glycolate and magnesium stearate etc. These agents can significant effect on dissolution properties of water insoluble drugs.


FORMULATION AND EVALUATION OF CHEWABLE TABLETS OF MEBENDAZOLE BY DIFFERENT TECHNIQUES

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About Authors:
Fiza Farheen*, Sudhir Bharadwaj
Department of Phrmaceutics, Shri Ram College of Pharmacy,
Banmore, Morena (M.P.)
fizafarheen31@gmail.com

Abstract
The objective of the study was to develop an effective formulation of mebendazole chewable tablets. Mebendazole is a benzimidazole derivative with broad spectrum anthelemthic activity and excellent tolerability. Orally it is rapidly absorbed and metabolized tohydroxy  andhydroxyamino, which may be responsible for its anthelmenthic action. It is widely used in the treatment of worm infestations in both humans and animals. Mebendazole chewable tablets (200 mg) were prepared by three methods viz. non aqueous granulation, aqueous granulation and direct compression and were named as NAG, AG and DC respectively. Tablet prepared by these three methods were evaluated by different parameters such as average weight, hardness, carr’s index, tapped density, friability, disintegration, content uniformity test, in-vitro dissolution etc. All the parameters were found within the specifications. The study on the dissolution profile revealed that product ‘DChad faster dissolution rate while compared to remaining batches and marketed product. Assay values were within the limits of 90% to 110%.


A REVIEW ON OSMOTICALLY REGULATED SYSTEMS

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About Authors:
Fiza Farheen*, Sudhir Bharadwaj
Department of Pharmaceutics, Shri Ram College of Pharmacy banmore,
Morena (M.P.) india
fizafarheen31@gmail.com

Abstract
Osmotic devices are most promising strategy based systems for controlled drug delivery. These are among the most reliable controlled drug delivery systems and could be employed as oral drug delivery systems or implant able devices. Osmotic pumps offer many advantages over other controlled drug delivery systems, i.e. they are easy to formulate and simple in operation, improve patient compliance with reduced dosing frequency and more consistent and prolonged therapeutic effect with uniform blood concentration. Drugs can be delivered in a controlled pattern over a long period of time by the process of osmosis. Osmotic pumps consist of an inner core containing drug and osmogens, coated with a semi permeable membrane. As the core absorbs water, it expands in volume, which pushes the drug solution out through the delivery ports. This article highlights the principle of osmosis, materials used for fabrication of pumps, types of pumps, advantages, disadvantages, and marketed products of this system.


HISTORY OF CATIONIC VS ANIONIC: IN NASAL DRUG DELIVERY SYSTEM

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ABOOUT AUTHORS:
Manu Sharma1, Shikha Chaudhary1, Dharmendra Kumar2*
1 R.V.Northland institute, greater Noida, Dadri, UP, India
2
Brahmanand Group of Institution, 195, Khurja G.T Road, Buldshahar Uttar Pradesh, India.
*rvnimiet@gmail.com

ABSTRACT
Chitosan as cationic and pectin as anionic are natural polysaccharides which show great potential in nasal drug delivery system. Chitosan’s are strongly poly-cationic. They are derivatives of poly-N-acetyl-D-glucosamine. Chitosan’s have positive charge that is responsible for mucoadhesion and play an important role in nasal drug delivery system Pectin’s have several structural elements: Homogalactouronan are smooth and Rhamnogalactouronan are hairy which play a very important role.By methyl esterifications, pectin’s are divided in two types: High methoxypectin’s and low methoxypectin’s. Low methoxypectin’s are very important in the formulation of nasal gel, because they have properties to form the gel with calcium ion (Ca2+).


SOLID DISPERSION: A TOOL TO ENHANCE SOLUBILITY OF POORLY WATER SOLUBLE DRUGS

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ABOUT AUTHORS:
Ravindra M Hanwate*1, Dehghan M H G2, Saifee M2
1Department of Pharmaceutics, Dr.Vedprakash Patil College Of Pharmacy, Auranganad, Maharashtra, India
2Department of Pharmaceutics, Y.B.Chavan College of Pharmacy, Aurangabad, Maharashtra, India
* ravi_hanwate@yahoo.co.in

ABSTRACT
Solid dispersions have been used to increase the dissolution rates of poorly water soluble drugs. Many methods are used to prepare solid dispersions. This paper reports various solubility enhancement strategies in solid dispersion. The methods described are fusion (melting), solvent evaporation, lyophilization (freeze drying), melt agglomeration process, spray drying technology, use of surfactant. The paper also shows study of characterization, selection of carriers, potential applications and limitations of these methods in solid dispersion.


ENHANCEMENT OF SOLUBILITY CHARACTERISTICS OF ALPRAZOLAM

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ABOUT AUTHORS:
Sandeep.M1*, Das Saumya1, Joe Cherry Divya2, J. Tarun1, B. Kiran kumar1
1Department of Pharmaceutics, Vikas College of Pharmaceutical Sciences, Rayanigudem, Suryapet, Nalgonda, Andhra Pradesh, India
2Department of Pharmaceutics, Nalanda College of Pharmaceutical Sciences, Cherlapally, Nalgonda, Andhra Pradesh, India
sandeepm005@gmail.com

ABSTRACT
Alprazolam is an anti-anxiety with sedative and hypnotic actions and used in treatment of anxiety and panic disorders. It is practically insoluble in water and hence has a less bioavailability. In the present study attempt has been made to prepare and characterize inclusion complexes of alprazolam with HP-β-CD and PEG6000 (Polyethylene glycol6000). The phase solubility analysis indicated the formation of 1:1 molar inclusion complex of alprazolam with HP-β-CD and PEG6000. The inclusion complexes were prepared by two different methods viz. physical and kneading methods. The complexes were characterized using Fourier transform infrared spectroscopy and differential scanning calorimetry. The complexes prepared by physical method with HP-β-CD exhibited greatest enhancement in solubility and fastest drug release of 90.29% and kneading method with PEG6000 exhibited greatest enhancement in solubility and fastest drug release of 90.19%.


REVIEW: AN OVERVIEW ON FLOATING DRUG DELIVERY SYSTEM

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About Authors:
Hemant Maheta, MR Patel, KR Patel, MS Patel
Department of Pharmaceutics,
Shri B.M.Shah College of Pharmaceutical Education and Research,
College Campus, Modasa-383315, Gujarat, India.
hsmehta19@gmail.com

Abstract:
The purpose of writing this review on floating drug delivery systems was special focus on the principle mechanism of floatation to achieve gastric retention. Conventional oral dosage forms has short residence times & unpredictable gastric emptying time. The idea of gastric retention comes from the need to localize drugs at a specific region of gastrointestinal tract (GIT) such as stomach in the body. Many drugs get absorbed only in the upper intestinal tract, designing such molecules as once-daily formulations are exclusive for these molecules. Thus GI retention platforms had emerged. Gastroretentive drug delivery systems are designed to be retained in the stomach for a prolonged time. Gastroretentive drug delivery systems have potential for use as controlled release drug delivery system. The use of floating drug delivery system is one method to achieve prolonged gastric residence times, providing opportunity for both local & systemic drug action. Thus, gastroretention could help to provide greater availability of new products and consequently improved therapeutic activity and substantial benefits to patients. This article aims at reviewing the floating drug delivery system including types, approaches for designing the floating dosage form, advantages & disadvantages of FDDS.


A REVIEW: FORMULATION OF FAST DISSOLVING TABLET

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ABOUT AUTHORS:
Patel Zinkal K.*, Patel Rahul R, Dr Kanu R Patel, Dr Mukesh R Patel
Department of Pharmaceutics,
Shri B.M. Shah College of Pharmaceutical Education and Research
Dhansura Road College campus Modasa, Dist:- Arvali. Pin code:- 383315 Gujarat, (india)
*zinkal.pharm27@yahoo.in, rahulrpatel21089@yahoo.com

ABSTRACT
As pharmaceutical scientists are attaining a better understanding of biochemical and physicochemical properties related to the drug action, the drug delivery systems are becoming simple. Recent advances in Novel Drug Delivery Systems (NDDS) aim for designing dosage forms, convenient to be manufactured and administered, free of side effects, offering immediate release and enhanced bioavailability, so as to achieve better patient compliance Oral delivery is currently the gold standard in the pharmaceutical industry where it is regarded as the safest, most convenient and most economical method of drug delivery. Fast dissolving tablet is designed to allow administration of an oral solid dose form in the absence of water or fluid intake. Such tablets when put on the tongue. it readily dissolve or disintegrate in the saliva without chewing or water within <60 seconds. Fast- or mouth dissolving tablets have been formulated for pediatric, geriatric, and bedridden patients and for active patients who are busy and traveling and may not have access to water. This review includes requirements for fast disintegrating tablets, sailent features, advantages, limitations, challenges in formulation, various technologies developed for fast disintegrating tablets, patented technologies, evaluation methods and various marketed products.


FUTURISTIC DRUG DELIVERY SYSTEM MICROEMULSIONS : A REVIEW

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ABOUT AUTHORS:
Shingitha K.P
Department of Pharmacy
Noida Institute Of Engineering And Technology Greater NOIDA, G.B Nagar
shingithanair@gmail.com

ABSTRACT
Recently microemulsion have attracted great attention as they help to optimize efficiency of wide range of products and processes. Microemulsion are isotropic, thermodynamically stable multicomponent fluids which is composed of water, oil, surfactant or cosurfactant where the diameter of the droplet of the microemulsion is in the range of 100 Å TO 1000 Å. Microemulsion are unique class of optically transparent (translucent) solution which comprises of the colloidal system that are attracting many scientific and technological interest past few decades.This interest is due to their properties like ultra low interfacial tension, large interfacial tension and solubilization capacity of both oil and water soluble drugs.


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