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  • ENHANCEMENT OF DISSOLUTION OF POORLY WATER SOLUBLE DRUG USING SUPER DISINTEGRANTS BY KNEADING METHOD

    About Authors:
    YASWANTH ALLAMNENI1*, PAVAN POTTURI1, RAJKUMAR NULU2, RAVADA RAMESH3, P DAYANANDA CHARY1, ARUN KALEKAR1.
    1Research and Development Department, Natco Pharma Limited, Kothur, Mahaboobnagar,Andhra Pradesh, India-509228.
    2Research and Development Department, Aurobindo Pharma Ltd., Hyderabad, Andhra Pradesh, India.
    3HOD, Dept. of Pharmaceutics, Dr. H.L.T. College of pharmacy, Kengal, Channapatna, Banglore(R).

    *yaswanthallamneni@gmail.com

    ABSTRACT
    The aim of this study was to investigate the influence of superdisintegrants on the dissolution properties of a poorly water-soluble drug from complexes prepared by kneading method. Ketoprofen was employed as a model drug. Solid dispersions prepared by kneading method exhibited higher dissolution rate and DE30 values in each case. Ketoprofen tablets were prepared by direct compression technique using microcrystalline cellulose as a directly compressible vehicle. The formulated tablets were evaluated by different In Process Quality Control tests, content uniformity and in vitro drug release study. The FTIR spectra’s study revealed that there were no interaction between polymers and drug. All the tablets formulated employing solid dispersions in superdisintegrants gave rapid and higher dissolution of Ketoprofen when compared to that of Ketoprofen plain tablets. Ketoprofen dissolution from all the tablets followed first order kinetic with correlation coefficient ‘r’ above 0.9470. All dissolution parameters (k1, DE30 and T30) indicated rapid and higher dissolution of Ketoprofen from tablets formulated employing its solid dispersions in superdisintegrants when compared to plain tablets.

  • PREPARATION AND IN VITRO EVALUATION OF NIMESULIDE TRANSDERMAL PATCHES

    About Author:
    K. Sravan Kumar*
    Department of Pharmaceutics,
    Seshachala College of Pharmacy,
    Puttur-517 583, 
    Chittoor (dist), A.P., India
    *sravank681@gmail.com

    Abstract:
    In this study, transdermal patches containing Nimesulide were prepared using different ratios of polyvinylpyrrolidone (PVP) and Hydroxy propyl methyl cellulose (HPMC) by solvent evaporation technique using 10%w/w of dibutyl phthalate incorporated as plasticizer. The drug matrix film of PVP and HPMC was casted on a polyvinylalcohol backing membrane that was previously dried at 600C for 6 hrs. All the prepared formulations were subjected to physical studies (moisture content, moisture uptake, Tensile strength, flatness and Drug content determination), in vitro release studies and in vitro skin permeation studies. The physiochemical compatibility of the drug and the polymers studied by IR spectroscopy have absence of any incompatibility. In vitro permeation studies were performed across  skin using a Franz diffusion cell. Variations in drug release profiles among the formulations studied were observed. Based on a physicochemical and in vitro skin permeation study, formulation F1 (PVP/HPMC, 5:1) and F5 (PVP/HPMC, 1:5) were chosen for further in vivo experiments. The anti inflammatory effect and a sustaining action of Nimesulide from the two transdermal patches selected were studied by inducing paw edema in rats with 1% w/v carrageenan solution. Hence, it can be reasonably concluded that Nimesulide can be formulated into the transdermal matrix type patches to sustain its release characteristics.

  • DEVELOPMENT AND EVALUATION OF ANTI DANDRUFF HAIR STYLING GEL CONTAINING FLUCONAZOLE AND ZINC PYRITHIONE

    About Authors:
    Dinesh Kumar Jain*, Gajanan Darwhekar, Kapil Mahesh Dutt Swami
    College of Pharmacy,
    IPS Academy, Rajendra Nagar,
    AB Road, Indore.
    M.P. India.

    *swamikpl@yahoo.com

    ABSTRACT
    Dandruff and seborrheic dermatitis are the common clinical conditions caused by increased growth of fungi and bacteria on the scalp which results in abnormal proliferation, scaling and flaking of scalp epidermis. In present study an attempt was made to develop hair styling gel of Fluconazole, zinc pyrithione and their combination using different concentration of carbopol 940. The formulations were evaluated and compare for rheology, pH, active content, in vitro drug release, ex vivo drug release, in vitro antidandruff activity and in vivo antidandruff activity. All the formulation are homogenous, transparent and stable but formulation HG1, HG7 and HG11 shows high clarity, optimum rheology, high drug content and  drug release, so these three formulations were evaluated for in vitro antidandruff activity. HG11 shows higher zone of inhibition then HG1 and HG7 therefore HG11 was selected for skin irritation test, in vivo study and stability study. HG11 does not show any skin irritation hence it could be an effective formulation for treatment of dandruff and seborrheic dermatitis as compare to other.

  • A REVIEW ASPECTS ON PROBIOTIC AND PREBIOTIC A SYNERGESTIC COMBINATION

    About Authors:
    Kapil Sharma*, Priyanka sharma**
    *Yaresun Pharmaceutical Pvt Ltd,India
    **M.sc. Student, Rajasthan, India

    *pharma_kapil@rediffmail.com

    1. INTRODUCTION
    The mammalian intestinal tract contains a complex and diverse society of both pathogenic and non pathogenic bacteria. Most research to date has focused on the mechanism by which pathogenic bacteria achieve their detrimental effect. However, more recent research has unveiled a glimpse into the mechanism of action and potential therapeutic role of indigenious non pathtogenic microorganisms (probiotic).
    Probiotic, prebiotic, and synbiotic are moving from snake oil into the mainstream of medical therapy. This evolution has been facilitated by our ever increasing understanding of the mechanism of action of these agents and by the development of molecular method for analyzing and identifying complex bacterial community within the mammalian intestine.1, 2

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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.

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