• PharmaTutor
    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.

  • 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
    MANUFACTURING DOCUMENTATION IN PHARMACEUTICAL INDUSTRY- DEVELOPMENT AND IMPLEMENTATION

    About Authors:
    Krunal Parikh1*, 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.

    [adsense:336x280:8701650588]

  • 20 November 2012
    ENHANCEMENT OF SOLUBILITY BY LIQUISOLID TECHNIQUE: A REVIEW

    About Authors:
    Patel Chirag J1*, Satyanand Tyagi2, Patel Jaimin1, Chaudhari Bharat1, Tarun Parashar3, Soniya3
    1Maharishi Arvind Institute of Pharmacy, Department of Pharmaceutics, Jaipur, Rajasthan.
    2President, Tyagi Pharmacy Association & Scientific Writer (Pharmacy), Chattarpur, New Delhi, India.
    3Department of Pharmaceutics, Himalayan Institute of Pharmacy and Research, Rajawala,     Dehradun, Uttarakhand, India. 
    *Mr. Patel Chirag has published various books, research and review articles. His academic works include 16 Publications (2 books were published in Lambert Academic Publishing, Germany & 8 Research Articles and 6 Review Articles were published in standard and reputed National and International Pharmacy Journals).
    chirag.bangalore@gmail.com

    ABSTRACT
    Solving solubility problems is a major challenge for the pharmaceutical industry with developments of new pharmaceutical products, since nearly half of the active substances being identified are either insoluble or poorly soluble in water soluble. Various techniques are used for the enhancement of the solubility of poorly soluble drugs which include Liquisolid technique, 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.The “Liquisolid” technique is a novel and capable addition towards such an aims for solubility enhancement and dissolution improvement, thereby it increases the bioavailability.Liquisolid technique is based upon the admixture of drug loaded solutions with appropriate carrier and coating materials. The use of non-volatile solvent causes improved wettability and ensures molecular dispersion of drug in the formulation and leads to enhance solubility. By using hydrophobic carriers (non-volatile solvents) one can sustained the release of drugs by this technique. Liquisolid compacts demonstrated a considerably higher drug dissolution rates than those of conventionally made capsules and directly compressed tablets. This was due to the increased wetting properties and surface of drug available for dissolution. By using this technique, solubility and dissolution rate of water insoluble drugs can be improved. This review paper highlights the advantages, disadvantages, mechanism of enhanced drug release, classification, evaluation and application of liquisolid technique to enhance the solubility and dissolution of water insoluble drugs.

  • 19 November 2012
    ESSENTIAL ELEMENTS OF PATENT

    About Authors:
    Jatin  Patel1*, Prof. Rajesh Kumar Dholpuria2, Dhiren Shah1
    2(Professor, Head of Department of pharmacognosy),
    1Seth G.L. Bihani S.D. College of Technical Education,
    Institute of Pharmaceutical Sciences and Drug Research,
    Sri Ganganagar, Rajasthan, INDIA
    *Patelj313@yahoo.in

    ABSTRACT
    Patent Right varies from country to country. In India the law which govern patent right is "Indian Patent Act 1970". Indian Patent Act, 1970 grants exclusive right to the inventor for his invention for limited period of time. Generally 20 years time has been granted to the patent holder but in case of inventions relating to manufacturing of food or drugs or medicine it is for seven years from the date of patent. There is certain legal procedure which needs to be followed in order to register. There are several attorney helping inventor in patent registration by providing them best well informed knowledge. In India patent registration can be filed individually or jointly. In case of deceased inventor this can be done his legal representative on behalf of him. All the required documents need to be filed along with the application form. Only after verification registration certificate is provided to the applicant.

  • 14 November 2012
    PACKAGING AND LABELLING CONTROL ACCORDING TO GLOBAL GMP

    About Authors:
    *Tarun Patel, Prof. Dr. Vipin Kukkar, Krunal Parik
    Seth G.L. Bihani S.D. College of Technical Education,
    Institute of Pharmaceutical Sciences and Drug Research,
    Sri Ganganagar, Rajasthan, INDIA
    *tarunpatel35@gmail.com

    ABSTRACT:
    In pharma industry Packaging and Labelling plays very important role for improvements of attraction to human beings. So by improving our packaging and labeling style we can easily improve our product market value. Green packaging is also an alternative to make packaging more environmental friendly which would not affect the nature in any way. The most desirable solution is “use less, discard less, save more, reuse more”In this review article we discuss briefly about the requirement of packaging and labeling control of product according to different GMPs.

    [adsense:336x280:8701650588]

  • 9 November 2012
    EVALUATION OF CRUDE DRUGS, MONO OR POLYHERBAL FORMULATION

    About Authors:
    Dhiren Shah*1, Jatin Patel, Krunal Parikh
    m.pharmacy
    Seth G.L. Bihani S.D. College of Technical Education, R.U.H.S.
    Sri Ganganagar, Rajasthan, INDIA
    *dhiren.pharmacist@gmail.com

    Abstract :
    Involved Evaluation and Standardization techniques for crude drugs, mono or Polyherbal Frormulation. They involved the macroscopic techniques, microscopic techniques, physical evaluation and biological evaluation. They also involved the Quantitative analysis of Organophosphorus insecticides, Organochlorine and pyrethroid insecticides, microbial content determination.

  • 7 November 2012
    APPLICATION OF LC-MS

    About Authors:
    Jatin  Patel1*, Prof. Rajesh Kumar Dholpuria2, Dhiren Shah1
    2(Professor, Head of Department of pharmacognosy),
    1Seth G.L. Bihani S.D. College of Technical Education,
    Institute of Pharmaceutical Sciences and Drug Research,
    Sri Ganganagar, Rajasthan, INDIA
    *Patelj313@yahoo.com

    ABSTRACT:
    Liquid chromatography is a fundamental separation technique in the life sciences and related fields of chemistry. Unlike gas chromatography, which is unsuitable for nonvolatile and thermally fragile molecules, liquid chromatography can safely separate a very wide range of organic compounds, from small-molecule drug metabolites to peptides and proteins. Traditional detectors for liquid chromatography include refractive index, electrochemical, fluorescence, and ultraviolet-visible (UV-Vis) detectors. Some of these generate two- dimensional data; that is, data representing signal strength as a function of time. Others, including fluorescence and diode- array UV-Vis detectors, generate three-dimensional data. Three-dimensional data include not only signal strength but spectral data for each point in time. Mass spectrometers also generate three- dimensional data. In addition to signal strength, they generate mass spectral data that can provide valuable information about the molecular weight, structure, identity, quantity, and purity of a sample. Mass spectral data add specificity that increases confidence in the results of both qualitative and quantitative analyses. For most compounds, a mass spectrometer is more sensitive and far more specific than all other LC detectors. It can analyze compounds that lack a suitable chromophore. It can also identify components in unresolved chromatographic peaks, reducing the need for perfect chromatography. Mass spectral data complements data from other LC detectors. While two compounds may have similar UV spectra or similar mass spectra, it is uncommon for them to have both. The two orthogonal sets of data can be used to confidently identify, confirm, and quantify compounds.

  • 6 November 2012
    ROLE OF HULK PROTEIN- “GRB 10” IN ENHANCEMENT OF MUSCLE MASS: A CLINICAL REVIEW

    About Authors:
    Mr. Satyanand Tyagi*, Patel Chirag J1, Devesh Kaushik2
    *President, Tyagi Pharmacy Association & Scientific Writer (Pharmacy), Chattarpur, New Delhi, India-110074.
    Prof. Satyanand Tyagi is a life time member of various pharmacy professional bodies like IPA, APTI and IPGA. He has published various research papers and review articles. His academic work includes 60 Publications (50 Review Articles, 08 Research Articles and 02 Short Communications of Pharmaceutical, Medicinal and Clinical Importance, published in standard and reputed National and International Pharmacy journals; Out of 60 publications, 11 are International Publications).
    He has published his papers almost in different specialization of Pharmacy field...His research topics of interest are neurodegenerative disorders, diabetes mellitus, cancer, rare genetic disorders, psycho-pharmacological agents as well as epilepsy.
    1Department of Pharmaceutics, Maharishi Arvind Institute of Pharmacy, Mansarovar, Jaipur, Rajasthan, India-302020.
    2Territory Business Manager, Diabetes Division, Abbott Healthcare Private Limited, Okhla, New Delhi, India- 110020.
    *sntyagi9@yahoo.com, +91-9871111375/9582025220

    ABSTRACT:
    A group of Australian researchers at the Garvan Institute in Sydney have conducted a study indicating how Grb10 protein plays a crucial role in increasing muscle mass during development. Growth factor receptor-bound protein 10 also known as insulin receptor-binding protein Grb-IR is a protein that in humans is encoded by the GRB10 gene. The product of this gene belongs to a small family of adapter proteins that are known to interact with a number of receptor tyrosine kinases and signaling molecules. This gene encodes a growth factor receptor-binding protein that interacts with insulin and insulin-like growth-factor receptors (e.g., IGF1R and IGF2R). Over expression of some isoforms of the encoded protein inhibits tyrosine kinase activity and results in growth suppression. This gene is imprinted in a highly isoform- and tissue-specific manner. Alternatively spliced transcript variants encoding different isoforms have been identified.Scientists have discovered a way to build bigger and stronger muscles without having to lift a finger.

  • 6 November 2012
    TRANSDERMAL PATCHES: A REVIEW

    About Authors:
    Patel Chirag J1*, Satyanand Tyagi2, Patel Jaimin1
    1Maharishi Arvind Institute of Pharmacy, Department of Pharmaceutics, Jaipur, Rajasthan.
    2President, Tyagi Pharmacy Association & Scientific Writer (Pharmacy), Chattarpur, New Delhi, India.
    *chirag.bangalore@gmail.com, +918000501871

    ABSTRACT:
    Now a day about 74% of drugs are taken orally and are found not to be as effective as desired either due to bioavailability problems or degradation of drug in acidic pH of stomach. To resolve such problems, transdermal drug delivery system (TDDS) was emerged. Transdermal drug delivery systems are dosage forms involves drug transport to viable epidermal and dermal tissues of the skin for local therapeutic effect while a very major fraction of drug is transported into the systemic blood circulation. Transdermal drug delivery systems, also known as ‘‘patches,’’ are dosage forms designed to deliver a therapeutically effective amount of drug across a patient’s skin. This review article provides an overview of TDDS, advantages, limitations, various components of TDDS, methods of preparation, types of transdermal patches, factors affecting transdermal permeation, evaluation parameters and new approaches in TDDS.

    [adsense:336x280:8701650588]

Subscribe to Rajasthan