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  • Pharmaceutical Process Validation: A CGMP Concept

    About Authors:
    Satinder Kumar
    Manav Bharti University,
    Solan (H.P)

    skcrock87@yahoo.in

    Abstract:-
    Validation is the most recognized and important parameter of GMPs. This article provide introduction about the process validation of pharmaceutical manufacturing process and its importance according to The U.S. Food and Drug Administration (FDA). This work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process. Quality cannot be ensured by sampling, testing, release of materials and products. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. Process validation of a process will ensure production of drug of reproducible quality. 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.

  • CYTOTOXIC EFFECT OF TAXOL AND VITAMIN E SUCCINATE COMBINATION IN COMPARISON WITH TAXOL ALONE ON MCF-7 BREAST CANCER CELL CULTURE BY MTT ASSAY

    About Author:
    Brijesh Borad,
    The University of London Metropolitan University,
    London, UK

    borad_brijesh@yahoo.com

    Abstract :-
    Breast cancer is widely spreaded type of cancer in women and responsible for high number of cancer death in women. Taxol has been already approved to be used for breast cancer by FDA. There have been several studies on the anti tumor activities of Vitamin E Succinate (VES) as complementary and alternative medicine. In present study, we investigated the cytotoxic effect of taxol-VES combination on MCF-7 breast cancer cell lines in comparison with taxol alone. MCF-7 cells are preffered because of higher sensitivity to estogens. MCF-7 cells were sub cultured in according to specifications of aseptic conditions by incubating at 37οC and 5%CO2. Cells were seeded in 24 well plate with culture medium and different concentration of different drug regimen ( taxol alone, VES alone, taxol-VES combination) for 72hrs. Cell viability can be checked by MTT cell viability assay. MTT assay uses a MTT dye which acts as a substrate for viable cell reductase enzyme. This enzyme reduces MTT yellow dye to purple colour formazan which is in proportional to viable cell eventually. The intensity of purple colour was measured by measuring absorbances at 570nM using spectrophotometer. The results of the study were plotted as %cell viability Vs concentration for each of three drug regimen. IC50 values for each drugs were calculated. Graphical and statistical analysis of results concluded that taxol-MCF combination has more inhibitory effect on MCF-7 breast cancer cell lines when treated for 72hrs in comparison with taxol alone and statistical analysis had concluded that results were significant enough to accept clinically to use in stratagic breast cancer therapy management.

  • DEVELOPMENT AND EVALUATION OF MUCOADHESIVE BUCCAL FILMS OF GLIBENCLAMIDE

    About Authors:
    SINGH GAURAV*, GOKULAN DR P.D., KINIKAR DHANANJAY, KUSHWAH MANOJ
    Shri Ramnath Singh Institute Of Pharmaceutical Science and Technology,
    Sitholi, Gwalior, M.P

    *gaurav.robby@gmail.com

    ABSTRACT
    Glibenclamide is an oral hypoglycemic drug with very low aqueous solubility. The drug is completely metabolized in liver, its principle metabolite being very weakly active, buccal film may be more efficacious for the treatment of diabetes. The objective of this work is to investigate the feasibility of obtaining the slow release, obtaining relatively constant levels of Glibenclamide from buccal films. The films were fabricated by solvent casting technique with different polymers HPMC, Sodium CMC and PVP and systematically evaluated for in vitro and ex vivo performance. Propylene Glycol is employed as plasticizer and penetration enhancer. Hydroxypropyl methyl cellulose is acting as film forming polymer, Sodium CMC and PVP are employed as mucoadhesive polymer.  The formulation containing HPMC and Sodium CMC (F2) showed better controlled results correlated with ex vivo permeation studies.

  • MICROSPHERES: FORMULATION & EVALUATION

    About Authors:
    Piyush Gupta*
    Department of Pharmaceutics,
    Regional College of Pharmacy,
    Jaipur, Rajasthan

    ABSTRACT:-
    The term MICROSPHERE is defined as a spherical particle with size varying from 50nm to 2µm, containing a core substance. Microspheres are, in strict sense, spherical empty particles.However, the terms microspheres and microencapsulationare used synonymously. In addition, some related terms are “beads” are used alternatively. Spheres and spherical particles are also usedfor a large size and rigid morphology. The microspheres are characteristically free flowing powders consisting of proteins orsynthetic polymers, which are biodegradable in nature, andideally having a particle size less than 200 micrometer. Novel Drug Delivery Systems are developed to address the challengesof drug development such as Bioavailability, Permeability & Poor solubility. These demand changes in the conventional use of Excipients, the growth of the Biotechnology industry,including Stem cell therapy,Vaccines & Genetic products, also necessitates different drug delivery requirements, there by demonstrating the acceptance of these excipients by the US food & drug administration or other agencies in the major markets.For materials in which Toxicity is a possible concern, formulators can give information about the excipients regulatory acceptance& allowable amount by consulting with excipients manufactures& toxicology experts.

  • Evaluation of Antipyretic Activity of Ethanolic rhizome extract of Curcuma amada

    About Authors:
    AMRUTHA R.E.*, G.RAJESHWARI, A.SRILAKSHMI, C.RAJARAM
    Department of Pharmacology
    P. Rami Reddy Memorial College of Pharmacy,
    Andhra Pradesh, India.

    ABSTRACT
    Objective -
    The objective of the present work was to study the antipyretic activity of rhizome Curcuma amada Linn. belonging to family Zingiberaceae, known as “Amargandha” in Sanskrit & “Mamidiallam” in Telugu Materials & Methods: The ethanolic extract was taken for the study and evaluated for antipyretic activity using Brewer’s yeast induced pyrexia in Wister strain albino rats. The ethanolic extract at a dose of 100mg/kg & 200mg/kg were evaluated for antipyretic activity. Result - The extract of Curcuma amada plant showed a significant (P < 0.01) dose dependent antipyretic effect in yeast induced elevation of body temperature in experimental rats. Conclusion - The ethanolic extract of Curcuma amada Linn. plant have significant antipyretic activity when compared with the standard drug. So. It can be recommended for further studies.

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  • REGULATORY ASPECT OF CAPA IN QUALITY MANAGEMENT SYSTEM

    ABOUT AUTHOR:
    Devesh Sharma
    M.Pharm-DRA
    School of Pharmaceutical Sciences, JNU, Rajasthan

    Trainee, Chemist, Ind-swift labs ltd, Mohali, (punjab)
    devesh.m.pharmdra@gmail.com

    ABSTRACT:
    Corrective and Preventive Action (CAPA)is a concept within Good Manufacturing Practice (GMP). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence. To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventive actions undertaken. CAPA is part of the overall quality management system.CAPA is of paramount importance to the FDA. According to FDA documents CAPA accounts for 30-50% of FDA-483 forms issued for non compliance.

  • Evaluation of Anthelmintic Activity of Ethanolic root extract of Zizyphus Oenoplia

    ABOUT AUTHORS:
    AMRUTHA R.E.*, G.RAJESHWARI,  A.SRILAKSHMI,  G. JYOTHI REDDY, N.KRISHNA SREE,  SK. AFSAR.
    Department of Pharmacology
    P. Rami Reddy Memorial College of Pharmacy,
    Andhra Pradesh ,India.

    ABSTRACT
    Ethanolic extract of the roots of Zizyphus oenoplia were screened for its anthelmintic activity against Pheretima posthuma. The parameters like the time of paralysis and the time of death were determined by using the extract at the concentrations of 10, 20and 50 mg/ml. The extract exhibited significant anthelmintic activity at highest concentration of 50 mg/ml. Albendazole (20mg/ml) was used as standard reference and distilled water as control.

  • Formulation and In-vitro characterization of Gelatin Micro spheres loaded with Lisinopril dihydrate

    ABOUT AUTHORS:
    Sudha Talasila*1, Yamini Pendyala2, Deepthi Madhu3, Dr.K.L.Senthil kumar.
    1,2 Department of Pharmaceutics,
    Padmavathi College of Pharmacy and Reserch institute,
    periyanahalli, Tamilnadu, India.
    3 Department of Pharmaceutics, Gitams university,
    Visakhapatnam, India.

    ABSTRACT
    Aim of our present study was to formulate the Gelatin Microspheres Loaded with Lisinopril Dihydrate by using Co-acervation phase separation technique for control prolonged release of drug. Micro-particulate drug delivery of Lisinopril Dihydrate was prepared by using a blend of gelatin-carbopol 934P NF and Gelatin-Sodium alginate as release retardant.Lisinopril Dihydrate Microspheres were formulated by using different drug, gelatin-carbopol and gelatin-sodiumalginate in 6 batches was F1, F2, F3, F4, F5 & F6. All the formulations were investigated for various evaluation parameters like particle size, Bulk density, flow behavior, Entrapment efficiency, percentage yield and in vitro drug release etc. All the formulations showed good flow behavior. SEM study revealed that the spheres were almost spherical in shape with smooth surface. In-vitro drug release study showed that by increasing the polymer concentration the drug release of all the formulations were gradually decreased and the optimized formulation (F6) was able to sustain the drug release for 24 hours. So, it was concluded that gelatin microspheres loaded with Lisinopril Dihydrate can be prepared by Coacervation phase seperation  technique and used for sustaining the drug release for prolonged period of time.

  • A REVIEW ON FORMULATION AND EVALUATION ASPECTS OF ENTERIC COATED PELLETS

    About Authors:
    Kapil Sharma*, Priyanka Sharma**
    *M.Pharm, Yaresun Pharmaceutical Pvt Ltd, India
    **M.Sc, Yaresun Pharmaceutical Pvt Ltd,
    Rajasthan, India.

    1.PELLETS
    Pellets are spheres of varying diameter depending on the application and the wish of the producer. Applications are found not only in the pharmaceutical industry but also in the agribusiness (e.g., fertilizer, fish food) and in the polymer industry.
    In the pharmaceutical industry, Pellets can be defined as small, free-flowing, spherical particulates manufactured by the agglomeration of fine powders or granules of drug substances and excipients using appropriate processing equipment. The term also has been used to describe small rods with aspect ratios of close to unity.

  • HPTLC INSTRUMENTATION: AN OVERVIEW

    ABOUT AUTHORS:
    Arshad Hala
    Seth G. L. Bihani S. D. College of Technical Education,
    Institute of Pharmaceutical Sciences & Drug Research,
    Gaganpath, Sri Ganganagar, Rajasthan -335001, India

    ABSTRACT:
    HPTLC is one type of planar chromatography and most advanced form of instrumental TLC. Now a day, HPTLC is more useful than TLC and HPLC. Because HPTLC is independent of sample application, chromatogram development, detection, etc. it is not only instrumental TLC but entire concept that include widely standardize methodology based on validated method. It is instrument controlled by software. In this review article, we discussed about which type of instrument used in HPTLC, complete HPTLC methodology, How HPTLC better than TLC.

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