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  • VALIDATION AND SECURITY MEASURES FOR PHARMACEUTICAL DATA PROCESSING

    About Authors:
    Krunal Parikh1*, Maheshkumar Kataria2
    1 M.Pharm, Quality Assurance,
    2
    Assistant professor, Department of pharmaceutics,
    Seth 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
    The Quality System regulation requires that “when computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol.” This has been a regulatory requirement for GMP since 1978. In addition to the above validation requirement, computer systems that implement part of a regulated manufacturer’s production processes or quality system (or that are used to create and maintain records required by any other FDA regulation) are subject to the Electronic Records, Electronic Signatures regulation. This regulation establishes additional security, data integrity, and validation requirements when records are created or maintained electronically. These additional Part 11 requirements should be carefully considered and included in system requirements and software requirements for any automated record keeping systems.

  • STEM CELLS AND PEPTIDES TO BRAIN VIA INTRASNASAL ROUTE

    About Authors:
    Ms.Pratibha Chohan*, Mr.Prashant Mutha
    B.Pharmacy, G. D. Memorial College of Pharmacy, Jodhpur.
    *pmuthabiotech@gmail.com

    ABSTRACT:
    Brain is tightly segregated from the circulating blood by a unique membranous barrier, the blood – brain barrier (BBB). Many pharmaceuticals cannot be efficiently delivered to, or sustained within the brain; hence they are ineffective in treating a plethora of cerebral diseases. Therefore, drug delivery methods that can provide drug delivery to brain or eventually preferential brain delivery (i.e. brain targeting) are of particular interest. One technique that holds promise for bypassing the BBB to deliver drugs to the brain and eliminating the surgical risk and the spillover effect of drug to normal tissue is the intranasal delivery.

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  • Applications are invited for the positions of Hired contract based Researchers in G.B. Pant Institute of Himalayan Environment and Development

    G.B. Pant Institute of Himalayan Environment and Development (GBPIHED) was established in 1988-89, during the birth centenary year of Bharat Ratna Pt. Govind Ballabh Pant, as an autonomous Institute of the Ministry of Environment and Forests (MoEF), Govt.

  • ANALYSIS BY INSTRUMENTAL ANALYTICAL METHODS

    About Authors:
    Kapil Sharma*1, Subhash Gupta2
    1Yaresun Pharmaceutical Pvt. Ltd.,India.
    2Oasis test house ltd.jaipur-302006,rajasthan,india.
    *pharma_kapil@rediffmail.com

    INTRODUCTION
    Most of the manufacturing industries rely upon both qualitative and quantitative chemical analysis to ensure that the raw material used meet certain specification, and also to check quality of the final product. The unwanted compound may be harmful to manufacturing process or may appear as a harmful impurity in the final product.1

    A quantitative analysis is performed to establish the proportion of the essential component in the raw material. The final manufactured product is analyzed to ensure that its essential component is present within a predetermined range of composition and impurities do not exceed certain specified limit.

  • FORMULATION DESIGN, MANUFACTURE CRITERIA AND REQUIREMENT OF VARIOUS TYPES OF TABLET

    About Authors:
    1Sahu Deepak*, 2Ketawat Santosh
    1Ass.Professor, Geetanjali Institute of Pharmacy,
    2Lecturer, Geetanjali Institute of Pharmacy,
    Dabok, Udaipur [Rajasthan] – 313022
    *deepak.sahu.bhl@gmail.com

    Abstract
    Tablet is the most preferred oral dosage form, due to many advantages it offers to formulators as well as physicians and patients. However, the process of manufacturing tablets is complex. Hence, careful consideration has to be given to select right process, and right excipients to ultimately give a robust, high productivity and regulatory compliant product of good quality.

  • DIFFERENT METHODS OF ENHANCEMENT OF SOLUBILIZATION AND BIOAVAILABILITY OF POORLY SOLUBLE DRUGS: A RECENT REVIEW

    About Authors:
    Patel Chirag J*, Asija Rajesh, Asija Sangeeta
    Maharishi Arvind Institute of Pharmacy, Department of Pharmaceutics,
    Jaipur, Rajasthan.
    *chirag.bangalore@gmail.com

    ABSTRACT
    Solubility, the phenomenon of dissolution of solute in solvent to give a homogenous system, is one of the important parameters to achieve desired concentration of drug in systemic circulation for desired pharmacological response. Low aqueous solubility is the major problem encountered with formulation development of new chemical entities as well as for the generic development. The insufficient dissolution rate of the drug is the limiting factor in the oral bioavailability of poorly water soluble compounds. This review discusses BCS classification, carriers for solubility enhancement and different techniques for solubility enhancement.Various techniques are used for the enhancement of the solubility of poorly soluble drugs which include micronization, nanonization, sonocrystallization, supercritical fluid method, spray freezing into liquid and lyophilization, evaporative precipitation into aqueous solution, use of surfactant, use of co-solvent, hydrotropy method, use of salt forms, solvent deposition, solubilizing agents, modification of the crystal habit, co-crystallisation, complexation and drug dispersion in carriers.Selection of solubility improving method depends on drug property, site of absorption, and required dosage form characteristics.With the advent of combinatorial chemistry and a high throughput screening, the number of poorly water soluble compounds has increased solubility. A success of formulation depends on how efficiently it makes the drug available at the site of action.The purpose of this review article is to describe the techniques of solubilization for the attainment of effective absorption with improved bioavailability.

  • METHOD DEVELOPMENT AND ITS VALIDATION FOR ESTIMATION OF DEFLAZACORT IN TABLET DOSAGE FORM BY UV SPECTROPHOTOMETRY

    About Authors:
    Kapil Sharma*1, Subhash Gupta2, Priyanka Sharma1
    1Yaresun Pharmaceutical Pvt. Ltd.,India.
    2Oasis test house ltd.
    jaipur-302006,rajasthan,india.
    *pharma_kapil@rediffmail.com

    ABSTRACT
    This paper describe a simple, precise and economical spectrophotometric method for the quantitative determination of Deflazacort(DFCT) in tablet dosage form. Method is based on the estimation of DFCT in aqueous acetonitrileat 246 nm. Beer’s law was obeyed in the concentration range of 4-14 µg/ml. The accuracy of the method was assessed by recovery studies and was found to be 99.38±0.15 for DFCT. Results of the analysis were validated statistically so that it can be used for routine analysis of DFCT in tablet dosage form.

  • Vertigo Management – Mapping prevalence and treatment. Understanding once a day preparation usage and place in therapy.

    About Authors:
    Indraneel sinha*, Mr. Sanjay sahai, Mr. Sunil jajoo, Mr. Abhijeet bhatkar
    Post graduate diploma in pharmaceutical management,
    Indian institute of health management research,
    jaipur
    *indraneel.sinha.999@gmail.com

    COMPANY PROFILE
    Sun Pharmaceuticals was set up in 1983 and the company started off with only 5 products to cure psychiatric illness.  Sun Pharma is best known worldwide as the manufacture of specialty Active Pharmaceuticals Ingredients (API) and formulations.

    However, the company is also concerned with chronic treatments such as cardiology, psychiatry, neurology, gastroenterology, diabetology and   respiratory ailments. Active Pharmaceuticals Ingredients (API) includes peptides, steroids, hormones, and anti?cancer drugs and their quality is internationally approved. Mr. Dilip S. Shanghvi is the Executive Chairman and Managing Director of Sun Pharma and Mr. Kamalesh H. Shah is the secretary.

  • SIMULTANEOUS ESTIMATION OF ATORVASTATIN AND AMLODIPINE IN RAW MATERIAL AND IN COMBINED TABLET DOSAGE FORM BY RP-HPLC

    About Authors:
    Kapil Sharma*1, Subhash Gupta 2
    1 Yaresun Pharmaceutical Pvt. Ltd.,India.
    2 Oasis test house ltd. Jaipur-302006, Rajasthan, India.

    *pharma_kapil@rediffmail.com

    ABSTRACT
    A method for simultaneous estimation of Atorvastatin (ATVS) and Amlodipine (AMLD) in raw material and in combined tablet dosage form has been developed. The method employs the application of RP-HPLC. Chromatgraphy was carried out on a nucleosil C-18,250 x 4.6 mm column using a mixture of phosphate buffer and methanol  (50:50 v/v)  as the mobile phase at a flow rate of 1.3 ml/min.  Run time was 15 min.  Detection was done at 245 nm and retention time of ATVS was 6.97 min and 3.96 min of AMLD.3  This method produced linear responses in the concentration range 20-140 µg/ml and 10-70 µg/ml for ATVS and AMLD respectively. The accuracy of the method was assessed by recovery studies and was found to be 100.54± 0.19 and 100.08±0.80 for ATVS and AMLD respectively.The procedure was successfully applied for the simultaneous determination of both drugs in laboratory prepared mixture of raw material and in market available tablet dosage form. Results of the analysis were validated statistically so that it can be used for routine analysis of ATVS and AMLD in combined tablet dosage form.4-6

  • DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF TADALAFIL AND DAPOXETINE HCL IN SOLID DOSAGE FORM

    About Authors:
    CHIRAG S. RAJPARA*1, JAWED AKHTAR1, AMIT KHANDHAR2
    1. Department of Quality Assurance, School of Pharmaceutical Sciences, Jaipur National University, Jagatpura, Jaipur-302025, Rajasthan, India.
    2. Zydus cadila pharma, moraiya,ahmedabad.
    *chiragrajpara2601@gmail.com

    ABSTRACT
    * A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed for simultaneous estimation of Tadalafil and Dapoxetine HCL, Water Symmetry C-18 (150 x 4.6 mm),5 µ and a mobile phase composed of Buffer : Acetonitrile (65:35)

    * The retention time of Tadalafil and Dapoxetine HCL were found to be10.08 and 4.45 min respectively. Linearity was established for Tadalafil and Dapoxetine HCL in the range of 8.0-60 μg/ml and 24.0-180.0 μg/ml respectively. The percentage recovery of Tadalafil and Dapoxetine HCL were found to be in the range of 99.7-100.6% and 98.07-99.09% respectively. The drug was subjected to acid and alkali hydrolysis, oxidation, dry heat and photolytic degradation. The degradation studies indicated, Tadalafil showed degradation in acid and alkali while it was found stable in H2O2, photolytic and in presence of dry heat and Dapoxetine showed degradation in thermal and peroxide while it was found stable in rest of parameters . The degradation products of Tadalafil and Dapoxetine HCL in acidic, alkaline conditions were well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for the quantitative analysis of Tadalafil and Dapoxetine HCL in bulk drugs and formulations.

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