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  • REGISTRATION DOSSIER OF PHARMACEUTICALS

    About Authors:
    Apeksha Gupta
    Maharshi Dayanand University,
    Rohtak, India.
    apekshagupta87@gmail.com

    ABSTRACT
    The word “Dossier” has its English meaning as - a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. Any preparation for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “pharmaceutical product for human use”. Process of reviewing and assessing the dossier of a pharmaceutical product containing its detailed data (administrative, chemistry, pre-clinical and clinical)  and the permission granted by the Regulatory Agencies of a country with a view to support its marketing / approval in a country is called as the “Marketing Approval  or the “Registration” “Marketing Authorization” or the “Product Licensing”.
    “Registration Dossier” of the pharmaceutical product is a document that contains all the technical data (administrative, quality, nonclinical and clinical) of a pharmaceutical product to be approved / registered / marketed in a country. It is more commonly called as the New Drug Application (NDA) in the USA or Marketing Authorization Application (MAA) in the European Union (EU) and other countries, or simply Registration Dossier. Basically, this consists of data proving that the drug has quality, efficacy and safety properties suitable for the intended use, additional administrative documents, samples of finished product or related substances and reagents necessary to perform analyzes of finished product. Therefore, they are the vehicle in a country through which drug sponsors formally propose that the Regulatory Agencies approve a new pharmaceutical for sale and marketing.

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  • A REVIEW: PARENTERAL CONTROLLED DRUG DELIVERY SYSTEM

    About Author:
    Mahek Goel

    Shri Baba Mastnath Institute of Pharmaceutical Science & Research
    Asthal Bohar, Rohtak, Haryana (124001)
    mahekgoel10@gmail.com

    ABSTRACT
    Parenteral drug delivery systems are the preparations that are given other than oral route. (Para-outside, enteric–intestine). Parenteral drug delivery systems are most preferred drug delivery systems as they meet many benefits over other dosage forms in many cases such as unconsciousness, nausea, in emergency clinical episodes. The Parenteral administration route is the most common and efficient for delivery of active drug substances with poor bio-availability and the drugs with a narrow therapeutic index. But parenteral route offers rapid onset of action with rapid declines of systemic drug level. For the sake of effective treatment it is often desirable to maintain systemic drug levels within the therapeutically effective concentration range for as long as treatment calls for. It requires frequent injection, which ultimately leads to patient discomfort. For this reason, drug delivery system which can reduce total number of injection throughout the effective treatment, improve patient compliance as well as pharmacoeconomic. These biodegradable injectable drug delivery system offer attractive opportunities for protein delivery and could possibly extend patent life of protein drugs.Parenteral drug delivery system seeks to optimize therapeutic index by providing immediate drug to the systemic pool in required quantity to treat– cardiac attacks, respiratory attacks. This article explores various prolonged release parenteral drug delivery system and their strategies of preparation, their potential benefits/drawbacks and in-vitro testing methods.

  • Nanoparticles: An Overview

    About Authors:
    Mahek Goel
    Shri Baba Mastnath Institute of Pharmaceutical Science & Research
    Asthal Bohar, Rohtak, Haryana (124001)
    mahekgoel10@gmail.com

    Abstract:
    Nanoparticles are the preparations having size in nanometers. Particulate systems like nanoparticles have been used as a physical approach to alter and improve the pharmacokinetic and pharmacodynamic properties of various types of drug molecules. They have been used in vivo to protect the drug entity in the systemic circulation, restrict access of the drug to the chosen sites and to deliver the drug at a controlled and sustained rate to the site of action. Various polymers have been used in the formulation of nanoparticles for drug delivery research to increase therapeutic benefit, while minimizing side effects. Here, we review various aspects of nanoparticle formulation, characterization, effect of their characteristics, drug loading, in vitro release profile and their applications in delivery of drug molecules and therapeutic genes.

  • A COMPARATIVE RELEASE STUDY OF ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE FROM DIFFERENT VEHICLES BY USING DIFFERENT CHEMICAL ENHANCERS

    ABOUT AUTHORS:
    RANI SHALU1*, SAROHA KAMAL1, NANDA SANJU2
    1Institute of Pharmaceutical Sciences,
    Kurukshetra University, Kurukshetra 136119, Haryana, India.
    2Department of Pharmaceutical Sciences,
    MDU, Rohtak 124001,
    Haryana, India.

    ABSTRACT
    The aim of the present study was to investigate the in-vitro release properties of Ziprasidone hydrochloride monohydrate from different topical vehicles. By the unique advantages over the traditional drug delivery, transdermal drug delivery is becoming increasingly important and has got a vital interest in pharmaceutical industries. An in vitro release experiment was designed to reveal the rate of release of ziprasidone hydrochloride monohydrate from four different topical vehicles: (i) cream; (ii) a gel; (iii) an ointment (iv) pronoisomal gel. In vitro release of ziprasidone hydrochloride monohydrate from the four bases was monitored spectrophotometrically at a wavelength of 318 nm. In vitro release study results showed that the release of drug from vehicles ranks according to the following order: gel> proniosomal gel> cream> ointment. Gel base showed considerably higher drug release than other vehicles. Five types of chemical enhancers was used in the study and among them tulsi oil was the best enhancer. As we increase the concentration of chemical enhancer the release of drug also increases. By monitoring and attempting to explain the many possible reasons for the different rates of drug release from the vehicles, it was hope that the experiment would confer essential information concerning factors affecting the release of drugs from topical formulations.

  • Multiplace vacancies in Ahlcon Parenterals India | Require Sales Manager, Tewrritory Sales Manager

  • Walk-in: Opening for Project Fellow in Maharshi Dayanand University

    Maharshi Dayanand University, ab initio established as Rohtak University, Rohtak, came into existence by an Act No. 25 of 1975 of the Haryana Legislative Assembly in 1976  with the objective to promote inter-disciplinary higher education and research in the fields of environmental, ecological and life sciences.

  • Work as Assistant Professor in Maharshi Dayanand University - 2 Vacancies

    Maharshi Dayanand University, ab initio established as Rohtak University, Rohtak, came into existence by an Act No. 25 of 1975 of the Haryana Legislative Assembly in 1976  with the objective to promote inter-disciplinary higher education and research in the fields of environmental, ecological and life sciences.

  • Walk in : Post for Sales Officers, District Managers, Regional Sales Managers & Zonal Sales Managers in Ajanta Pharma

    Ajanta Pharma Limited is an emerging, global pharmaceutical company with proven capabilities in the areas of product research, manufacturing & marketing.

  • Area Sales Executive / Area Sales Manager / Regional Sales Manager Require in Health Biotech Ltd. - 5 Openings

    Health biotech is a company that promises good health for all by providing quality medicines at affordable prices and committed to care the people for keeping good health. Health Biotech has won many accolades in the domestic and international pharmaceutical domain.

  • Walk-in: Project Fellow in UGC sponsored Major Research Project at Maharshi Dayanand University

    Maharshi Dayanand University, ab initio established as Rohtak University, Rohtak, came into existence by an Act No. 25 of 1975 of the Haryana Legislative Assembly in 1976  with the objective to promote inter-disciplinary higher education and research in the fields of environmental, ecological and life sciences.

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