Articles

2 December 2012

IMPURITIES AN OVERVIEW

About Authors:
Lila dhar^*, Prof. Sanjeev Thacker, Jatin Patel
Seth G. L. Bihani S.D. College Of Technical Education, Institute Of Pharmaceutical Sciences & Drug Research,
Gaganpath, Sri Ganganagar, Rajasthan 335001
*ldbudania@gmail.com

ABSTRACT
Impurities is defined as an entity of drug substances or drug product that is not chemical entity defined as drug substances an excipients or other additives to drug product. In pharmaceutical world, an impurity is generally considered as an other organic material beside the other drug substances that is arises out of the synthesis most of the time, inorganic contaminants are not considered as an impurity unless they are toxic, such as heavy metal or arsenic. There are numerios source of impurities and many different common terms are use for impurities such as by product, intermediate, transformation on product, related product, interaction product and degradation products.
30 November 2012

Thermogravimetry

About Authors:
Jatin Patel^*
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Patelj313@yahoo.com

ABSTRACT:
Thermogravimetry is a branch of physical chemistry, materials research, and thermal analysis. It is based on continuous recording of mass changes of a sample of material, as a function of a combination of temperature with time, and additionally of pressure and gas composition.

It includes different types of Thermogravimetric analysis. In this article types, Instrumentation, Procedure, Application are priscribed.
30 November 2012

NEW DRUG APPROVAL PROCEDURE IN INDIA

About Authors:
Jatin Patel^*, Krunal Parikh, Dhiren Shah
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Patelj313@yahoo.com

ABSTRACT:
A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs.
This article includes new drug approval process in different countries include India, Australia, European union, China etc.
New drug approval process in different countries are described in logarithmic representation.
29 November 2012

REVIEW ON THE LEAD OPTIMIZATION TECHNIQUES (PHASE-I)

About Authors:
Kambham Venkateswarlu*, D.Z.Suhasini
Department of Pharmacology,
Sri Lakshmi Narasimha College of Pharmacy (JNTUA), Pallur,
Chittoor, Andhra Pradesh, India.
*k.v.reddy9441701016@gmail.com

ABSTRACT:
Lead optimization techniques are deals that new discovery is to choose the compounds with a known pharmacological action and proceed to modify the molecular structure of the compound systemically to get a drug with desired properties pharmacological action and pharmacokinetics. The compounds of the drugs are choosing for the study is called as lead.

Generally the identification and synthesis of compounds which are structurally related to the lead compound and testing their pharmacological activity. In the process it is possible to find a better drug than the lead compound.

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29 November 2012

STABILITY-INDICATING RP- HPLC METHOD FOR ANALYSIS OF SITAGLIPTIN IN THE BULK DRUG AND IT’S PHARMACEUTICAL DOSAGE FORM

About Authors:
V.DEEPTHI *, POORNIMA.Y, DR.G.DEVALA RAO, T.SANDEEP REDDY
Department of Pharmaceutical Analysis,
K.V.S.R.Siddharthacollege of pharmaceutical sciences,
Vijayawada-520010, India.
*deepthi759@gmail.com

ABSTRACT
A novel stability-indicating RP-HPLC method has been develop and validated for quantitative analysis of Sitagliptin in the bulk drug and in its pharmaceutical dosage forms using Hypersil–BDS- C18 column (250x4.6mmi.d, 5µ particle size) with 10mM Phosphate buffer (PH-3.5): ACN 60:40%v/v as isocratic mobile phase enabled separation of the drug from its degradation products. UV detection was performed at 260 nm. The method was validated for linearity, accuracy (recovery), precision, sensitivity, ruggedness and robustness. The linearity of the method was excellent over the range 10–60μg/ml (correlation coefficient 0.999). The limits of detection and quantification were 0.21 and 0.640μg/ml, respectively. Recovery of Sitagliptinfrom the pharmaceutical dosage form ranged from 99.99 to 100.05%.

Sitagliptin was subjected to stress conditions (Hydrolysis (acid, base), oxidation,thermal and photo degradation) and the stressed samples were analysed by use of the method. Degradation was observed in acid, base, and 30% H2O2. The drug was stable under the other stress conditions investigated. The degradation products were well resolved from main peak. The forced degradation studies prove the stability indicating power of the method.
28 November 2012

PYRROLE, FURAN, THIOPHENE DERIVATIVES & PHARMACOLOGICAL ACTIVITIES: A REVIEW

About Authors:
C.P.Meher*, S.P.Sethy, M.Madhavi
^*Asst. Professor
Maheshwara Institute of Pharmacy,
Chitkul, Patancheru, Medak, A.P
*chaitanyameher84@gmail.com

ABSTRACT:
Medicinal chemistry and pharmaceutical chemistry are disciplines at the intersection of chemistry, especially synthetic organic chemistry, and pharmacology and various other biological specialties, where they are involved with design, chemical synthesis and development for market of pharmaceutical agents, or bio-active molecules (drugs).Very important part of above is the heterocyclic-chemistry. Now a days so many investigation are carried out for developing new chemical entities having suitability for human life. A lot of research work is going on presently for development of new heterocyclic derivatives.The present review article is concern with the three, five-membered heterocyclic compound pyrrole, furan & thiophene derivatives that show diverse pharmacological activities.
28 November 2012

PHYSICAL STABILITY TESTING OF DRUGS AND DRUG PRODUCTS

About Authors:
L.D.Budania
Seth G. L. Bihani S. D. College Of Technical Education,
Institute Of Pharmaceutical Sciences & Drug Research, Gaganpath,
Sri Ganganagar, Rajasthan 335001
*ldbudania@gmail.com

ABSTRACT:
Stability is an essential quality attribute for drug products. If there is any functionally relevant quality attribute of a drug product that changes with time, this evaluation checked by pharmaceutical scientist and regulators who quantify drug product stability and shelf life. The rate at which drug products degrade varies dramatically. E.g. radiopharmaceutical products. Since the evaluation of the stability of drug is highly specialized and esoteric nature. Drug stability concerns about drug product safety, efficacy, and quality, found it to appropriate. Stability studies are done through the regulatory agencies such as FDA and HPB (health protection branch).
27 November 2012

EFFECT OF PRUNUS AMYGDALUS (BATSCH) IN DIFFERENT MODELS OF ULCER

About Authors:
Devendra Kumar¹,Pragya Seth²
Department of Pharmaceutical technology,
¹Sri Satya Sai collage of Pharmacy Bhopal,
²Lakshmi Narain College of Pharmacy, Bhopal
*guptadevendra15@gmail.com

Abstract
The present work describes the effect of methanolic extract of Prunus amygdalus (batsch.) on pylorus ligation and Ethanol-induced gastric ulcer models in Wistar rats. The present study provides a strong evidence of antiulcer activity of Prunus amygdalus extract against gastric lesions. The antiulcer activity is recognized by a reduction in acid-secretary parameters like total and free acidity, gastric volume and ulcer score suggesting that acid inhibition accelerates ulcer healing, thereby strengthening of mucosal barrier. In this present study it shows significant protection for Hexosamine in all treated groups in comparison to negative control group. Inthe LPO results it was observed that there was significance level difference in negative control group and all other group that indicates that lipid peroxides enzyme was higher in vehicle treated group. Ulcer score was determined by the counting of spots and severity of damage in stomach part by any moiety such as ethanol. Single drug treatment (200 mg/kg and 400mg/kg of P.A.E.) was effective up to a significant level (P<0.05) in compare to negative control group.Volume of gastric juice indicate the secretions of gastric fluid and it is higher in negative control group and all drug treated group was effective in relation to negative control group in significance level (P <0.05).
27 November 2012

MANUFACTURING DOCUMENTATION IN PHARMACEUTICAL INDUSTRY- DEVELOPMENT AND IMPLEMENTATION

About Authors:
Krunal Parikh^1*, Mr. Maheshkumar Kataria², Jatin Patel¹
²Assistant professor, Department of pharmaceutics,
¹Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Krunal_2922@yahoo.in

ABSTRACT
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized. It consequently strengthens the quality, and its consistency, of all goods and services, as those responsible for the specific operations have clear, unambiguous instructions to follow including active drug substances, is legally mandatory.

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26 November 2012

NANOTECHNOLOGY IN MEDICINE

About Authors:
P.Ramanujaiah*, Dr M.Purushothaman, Hemalatha
Vasavi institute of pharmaceutical sciences, Kadapa
*rama.mpharm@gmail.com

Abstract:
The application of nanotechnology to drug delivery has currently more than 20 Nanoparticles therapeutics are in clinical use, validating the ability of Nanoparticles to improve the therapeutic index of drugs. In addition to the already approved Nanoparticles, numerous other Nanoparticles platforms are currently under various stages of preclinical and clinical development, including various liposomes, polymeric micelles, dendrimers, quantum dots, gold Nanoparticles, and ceramic Nanoparticles. With continued research and development efforts, nanotechnology is expected to have a tremendous impact on medicine for decades to come.