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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.


ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF PARACETAMOL AND PROPYPHENAZONE IN THEIR COMBINED PHARMACEUTICAL DOSAGE FORM BY SIMULTANEOUS EQUATION METHOD

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About Authors:
Mehul Kakdiya*1, Anup Patel2, Darshan Madiya1, Shital Faldu1
1Department of Quality Assurance, Smt. R. D. Gardi B. Pharmacy College, Rajkot, Gujarat, India
2B.M. Shah College of pharmaceutical Education and Research, Modasa, Gujarat, India
*kakdiyamehul@gmail.com

Abstract
UV Spectrophotometric method has been developed for simultaneous estimation of Paracetamol (PCM) and Propyphenazone (PP) in their combined pharmaceutical dosage form. This method utilizes methanol as a solvent and λmax of Paracetamol and Propyphenazone selected for analysis was found to be 249 nm and 274 nm respectively. Linearity was observed in the concentration range of 1-12 μg/ml for Paracetamol (r2=0.995) and 5-24 μg/ml for Propyphenazone (r2=0.997).The method was validated statistically and by recovery studies. The mean % recovery was 98.26-99.93% and 98.36-100.24% for Paracetamol and Propyphenazone respectively. Developed method was applied to pharmaceutical dosage form. The results were found to be within acceptance criteria according to ICH guideline. This method was simple, rapid, accurate and sensitive.


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%.


INVITRO AND IN VIVO EVALUATION OF ANTICANCER ACTIVITY OF BOERHAAVIA DIFFUSA LINN IN EXPERIMENTAL ANIMALS

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ABOUT AUTHORS:
Nandu Kayande1*, Pankaj Kushwah2
1HOD Department of Pharmacology
2Department of Pharmacognosy
Nimar Institute of Pharmacy, Dhamnod,
Opp.ITI, Maheshwar Road Dhamnod, Dhar. M.P.
nandu_kayande@rediffmail.com

ABSTRACT:
The antitumor activity of the ethanolic extract of leaves of boerhaavia diffusa L. (EBD) has been evaluated against Dalton’s ascitic lymphoma (DAL) in Swiss albino mice at the dose of 250 & 500 mg/kg, body weight. The experimental parameters used were tumour volume, tumour cell count, viable tumour cell count, mean survival time and increase in life span to assess antitumour activity. The extract administered orally for 14 consecutive days to tumor bearing group of animals. The extract increase the life span of DAL treated mice and restore the hematological parameters as compared with the DAL bearing mice in dose dependant manner. The study revealed that the EBD showed significant antitumour activity in tested animal models.


ANTIDIBETIC EVALUATION OF GYMNEMA SYLVESTRE EXTRACTS IN EXPERIMENTAL ANIMALS

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ABOUT AUTHORS:
Nandu Kayande1*, Pankaj Kushwah2
1Department of Pharmacology
2Department of Pharmacognosy
Nimar Institute of Pharmacy, Dhamnod,
Opp.ITI, Maheshwar Road Dhamnod, Dhar. M.P.
nandu_kayande@rediffmail.com

ABSTRACTS
The aim of presents study is to evaluate antidiabetic (Hypoglycemic) effect of Gymnema Sylvestre extract in alloxan induced diabetic Swiss albino mice. These aqueous extract were used for the study. The Swiss albino mice weighing 25 to 30 gm were used for the study.  Mice were administered orally with the aqueous extracts of Gymnema Sylvestrewith dose of 200 mg/kg, 400 mg/kg and 500 mg/kg. body weight from period of day 1 to 28 days. The study reveals that the all the three doses shows the significant decrease in blood glucose level. This study shows the significant activity of gymnema sylvestre extracts against alloxan induced diabetes.  These prove the guava fruit is pancreatic protective and hypoglycemic in nature.


ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF AMILORIDE AND TORSEMIDE IN THEIR COMBINED PHARMACEUTICAL DOSAGE FORM

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About Authors:
Krutika J. Bhalodiya*, Nehal Ghelani, Darshan Madiya, Shital Faldu
Department of Quality Assurance
Smt. R. D. Gardi B. Pharmacy College, Rajkot
bhalodiyakruti1@gmail.com

Abstract
UV Spectrophotometric method has been developed for simultaneous estimation of Amiloride (AML) and Torsemide (TSM) in bulk drug and in their combined dosage form by first order derivative. This method utilizes methanol as a solvent and λmax of Amiloride and Torsemide selected for analysis was found to be 248 nm(at ZCP of TSM) and 308 nm (at ZCP of AML) respectively. Linearity was observed in the concentration range of 4-14μg/ml for AML (r2 = 0.999) and 4-20 μg/ml for TSM  (r2 = 0.998). The accuracy and precision were determined and found to comply with ICH guidelines. This method showed good reproducibility and recovery with % RSD in the desired range. The proposed methods can be successfully applied for the routine analysis of both the drugs. This method was simple, rapid, accurate, and sensitive.


FORMULATION, DEVELOPMENT AND EVALUATION OF ANTI-IMPLANTATION ACTIVITY OF INTRAUTERINE SYSTEM OF CENTCHROMAN (SAHELI) USING WISTAR ALBINO RATS

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ABOUT AUTHORS:
Himani Devliyal*, S.S Agarwal
Department of Pharmacology,
Delhi Institute of Pharmaceutical Sciences and Research, Delhi University, New Delhi
himanidevliyal@gmail.com

ABSTRACT
Centchroman – A Non-steroidal, post-coital anti-implantation drug which is generally popular as SAHELI is one of the best agents available. The fundamental aim of this study  was to formulate such an Intra-uterine System of Centchroman which should be safe and acceptable. This new drug delivery system surpasses the first pass metabolism, thus increasing the bioavailability and reducing the drug load. This formulation delivered the drug upto 21 days. Polylactic-co-glycolic acid served as the best fit polymer for delivering the drug. The best optimized formulation was selected and subjected to stability studies.  The effect of the foreign bodies was also observed on the fertility, mating behaviour and estrous cycle of the rats along with anti-implantation activity of the IUS. This formulation was tested on Wistar albino rats and is proved to be safe at the optimized dose level. The formulation exhibited pre-implantation loss of 100% and post-implantation loss of 0% in Wistar albino rats at a particular dose when delivered on 1st day and 4th day post-coital. Experimental part on animals showed that any foreign body, if put inside the uterus would not affect the fertility unless the size is more than 6mm. Results showed that 3mm objects had no effect on fertility. The foreign bodies and the IUS showed neither any alteration in the estrous cycle nor on the mating behavior of the animals.


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.


FLASH CHROMATOGRAPHY: AREA & APPLICATIONS

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ABOUT AUTHORS:
Ayare P*, Khanvilkar V, Chalak N
Department of Quality Assurance,
Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai
abprachi@gmail.com

ABSTRACT
Most of the sophisticated analytical techniques like NMR, MS and FT-IR need sample in the extreme pure form which is usually achieved by Preparative column chromatography but it is time consuming. From past few decades, technique called as Flash chromatography is developed which is a modification of Preparative column chromatography. This is an air pressure driven technique comprising of medium and short column chromatography, optimised for rapid separation of organic compounds. Modern flash chromatographic system consists of pre-packed plastic cartridges wherein solvent is pumped through the cartridges to achieve separation. These systems are also linked with detectors and fraction collectors which can even be automated. It is a simple, fast and economic approach to preparative liquid chromatography for purification of chemical species.This review highlights the principle involved, instrumentation, general procedure and advancement in Flash chromatography along with its applications.