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  • Regulatory Affairs: an Overview

    About Authors:
    Dolita Shah*, Mayur Mistry1
    *M.Pharm (Q.A, Gold Medalist),
    Asst. Professor, Smt. R. B. Patel Mahila Pharmacy College
    1Production officer, Intas Pharmaceutical ltd,
    Ahmedabad, India

    Introduction
    A new molecule can cost several millions of rupees or dollars to progress and any blunder causes greater impact on company’s status. As medicines play a vital role in human’s life there must be regulations for medicines ensuring Quality, Safety and Efficacy of drugs. The regulatory affairs professional is the only one who is completely responsible for holding products in compliance and maintaining all the records. One of the vital activities of the regulatory specialist is to ensure that the all the information regarding medicines has been correctly established to the patient covering labelling also. Even a small mistake in any of the activities related to regulatory can make the product to be recall in addition to loss of several millions of the money.

  • Guidelines - Product Packing Compatibility

    About Author:
    Nitish Chhabra
    Arbro Phamaceuticals Ltd.(Analytical Divison), New Delhi
    Seth G.L. Bihani S.D. College of Technical Education,
    Sriganganagar, Rajasthan, INDIA

    INTRODUCTION
    The pharma packaging industry in India is still n a nascent stage. “First impression is the last impression; packaging plays a very important role in creation that impression for any product. But when it comes to pharmaceuticals, it has to go beyond looks”.
    The term “compatibility” encompasses three different consequences of chemical interaction between the package and any of the components of a drug product formulation.
    (1)The first results in actual reduction in drug availability or potency through sorption- the removal of the drug by the package.
    (2) The second result in contamination as the formulation extracts substances from the package.
    (3)The third cause’s breakdown of the package by deterioration of its strength, stiffness or barrier properties as the formulation chemically attacks the package

  • TRANSDERMAL PATCHES

    About Authors: 
    Shakya Pragati*, Khwaja Sadiya,
    Asst. Professor, Integral University,
    Lucknow,
    U.P, India

    1.ABSTRACT
    Transdermal delivery of medications was foreshadowed in earlier eras by the use of certain plasters and ointments. The mustard plaster, applied as a home remedy for severe chest congestion, may be considered an example. (This author remembers his mother making mustard plasters for members of the family.) Powdered mustard seed (Brassica nigra) was mixed with warm water, and the resulting paste was spread on a strip of flannel, which was applied to the patient’s chest with a cloth binding wrapped around the body to hold the plaster in place. The moisture and body warmth activated an enzyme (myrosin) in the mustard that hydrolyzed a glycoside (sinigrin), causing the release of the pungent active ingredient allyl isothio-cyanate (CH2=CHCH2NCS) (7). This substance possesses the qualifications listed above for transdermal absorption. A transdermal patch or skin patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the bloodstream.

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  • DENTIFRICES – A BRIEF REVIEW ON THE CUTTING EDGE DRUG DELIVERY SYSTEMS

    About Authors:
    RESHMY RAJAN
    DEPT OF PHARMACEUTICS, AMRITA SCHOOL OF PHARMACY,
    AIMS HEALTH CARE CAMPUS,
    KOCHI 682041

    ABSTRACT
    Dental diseases are recognized as a major public health problem, in civilized society. The prevalence of tooth decay, various dental diseases, and tooth loss are so great that a permanent healthy oral system in the body is almost impossible. Dental diseases are studied by oral examination of a particular section of the population and the incidence measured by the number of new cases occurring in a given period of time. In UK it is estimated that 99% of children under 12 years suffer from dental caries.  Modern dentifrices compositions contain numerous components that have various therapeutic and cosmetic functions. Fluoride was the first of the therapeutic additions to the basic dentifrice formulations. Most of the dental compositions contain an abrasive cleansing agent which aids in the removal of adherent deposits on the teeth. Advertising and taste rather than therapeutic superiority determine the market advantage. During the past decade, however, it has not been enough for a dentifrice to prevent tooth decay or create a smile that will win the man, woman or job of one's dreams. Now, it seems, a dentifrice must fight tartar, plaque and gum disease as well. And manufacturers do not want to forget "niche" consumers -smokers, natural product fans, people with tooth sensitivity, and those with dry mouths. Sustained-release delivery systems allocate extended drug action to treat dental and periodontal diseases compared to the conventional dosage forms. Herbal extracts have been successfully used in dentistry as tooth cleaning and antimicrobial plaque agents. Only two out of ten 5-year old have sound teeth according to the General Dental Council.The present review deals with the various novel formulations of dentifrices.

  • Spectrophotometric Methods for Simultaneous Estimation Of Pyrimethamine And Sulphadoxine In Bulk Drug And Pharmaceutical Formulations

    About Authors:
    Kalpesh N. Patel1*, Jayvadan K. Patel2
    1 Research Scholar, Jodhpur National University, Jodhpur,
    Rajshathan, India
    2 Department of Pharmaceutical Technology,

    Nootan Pharmacy College,
    Visnagar (GUJARAT), India.

    Abstract
    Two simple spectrophotometric methods have been developed for simultaneous estimation of pyrimethamine and sulphadoxine from tablet dosage form. Method-I simultaneous equation method involves the measurement of absorbances at two wavelengths 215 nm (λmax of pyrimethamine) and 254 nm (λmax of sulphadoxine) in methanol and Method-II first order derivative spectroscopic method involves the measurement of absorbances at two wavelengths 250 nm (λmax of pyrimethamine) and 220.5 nm (λmax of sulphadoxine); The linearity lies between 5-30 µg/ml for both pyrimethamine and sulphadoxine for all the two methods. The accuracy and precision of the methods were determined and validated stastically. All the methods showed good reproducibility and recovery with % RSD less than 2. All method were found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis of pyrimethamine and sulphadoxine in bulk and combined dosage form.

  • A REVIEW REPORT ON: COATING OF SOFT GELATIN CAPSULES

    About Authors:
    KAPIL V BIYANI1, DR.P.S. KAWTIKWAR2, N. M. MAHAJAN3
    1. M.Pharm, IBSS COLLEGE OF PHARMACY,
    BULDHANA ROAD, MALKAPUR (M.S)
    2. HOD, SNIOP, PUSAD
    3. HOD,
    IBSS COLLEGE OF PHARMACY,
    BULDHANA ROAD, MALKAPUR (M.S)

    Introduction1, 2, 3, 4, 5, 6, 7, 8
    Capsule is the most versatile of all dosage forms. Capsules are solid dosage forms in which one or more medicinal and inert ingredients are enclosed in a small shell or container usually made of gelatin. There are two types of capsules, “hard”and“soft”. The hard capsule is also called “two pieces” as it consists of two pieces in the form of small cylinders closed at one end, the shorter piece is called the “cap” which fits over the open end of the longer piece, called the “body”. The soft gelatin capsule is also called as “one piece”. Capsules are available in many sizes to provide dosing flexibility. Unpleasant drug tastes and odors can be masked by the tasteless gelatin shell. The administration of liquid and solid drugs enclosed in hard gelatin capsules is one of the most frequently utilized dosage forms.

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  • FORMULATION AND DEVELOPMENT OF HYDROCHLOROTHIAZIDE FLOATING MICROSPHERES

    About Authors:
    RAVIKUMAR R. PATEL1, Dr. JAYVADAN K. PATEL2
    1 Research Scholar, Jodhpur National University, Jodhpur
    2 Principal and Professor, Nootan Pharmacy College, Visnagar, Mehsana, Gujarat.

    AIM OF PRESENT INVESTIGATION
    Now a day most of the pharmaceutical scientists are involved in developing an ideal drug delivery system with an objective of not only curing the disease but also to achieve patient compliance. Approximately 50 % of the drug delivery system available in market is oral drug delivery system. Conventional oral dosage forms provide a specific drug concentration in systemic circulation without offering any control over drug delivery. Over the past three decades, the pursuit and exploration of devices designed to be retained in the upper part of gastrointestinal tract has advanced consistently in terms of technology and diversity, encompassing a variety of systems and devices such as floating systems.

  • Preparation of disintegration tablet using Cucurbita maxima pulp powder as disintegration

    About Authors:
    Madhu  dwivedi, Rishabha Malviya
    Department of pharmaceutical technology
    MIET,MEERUT

    Introduction:
    Natural polymer: A number of natural or partially modified polymers were screened for mucoadhesive properties by routinely measuring the force of detachment for swollen polymer films from pig intestinal mucosa in a saline medium. Suprisingly, hydroxypropyl- and carboxymethylcellulose showed almost no mucoadhesion, whereas the cationic polymer chitosan was fairly mucoadhesive in comparison to Polycarbophil as a reference substance. It is suggested that a strict difference be made between mucoadhesion of dry polymers on a wet tissue in air, and mucoadhesion of a swollen hydrogel in the presence of a third liquid phase. Cationic polymers should be further investigated with respect to possibly improved mucoadhesive properties in a neutral or slightly alkaline environment.

  • Stomach Specific Mucoadhesive-A Review

    About Authors:
    Shalini Sharma, Manoj Prashar
    Manav Bharti University,
    Solan

    ABSTRACT
    Stomach specific mucoadhesive drug delivery system(MADDS) is one of the most prominent and latest system which sustain drug blood concentration and controlling the rate of drug delivery to the target tissue. These systems interact with mucin molecule and mucous layer covering the mucosal epithelial surface and prolong the residence time of the dosage form at the site of application or absorption and thus contribute to improve or better therapeutic performance of drug. This review article also present the polymer used for preparation of mucoadhesive tablet, mechanism of mucoadhesion, factor affecting mucoadhesion and recent developments or techniques in formulation of mucoadhesive tablet and invitro and invivo evaluation of mucoadhesive tablets.

  • BUCCAL PATCHES

    About Authors:
    Sachin Saxena*1,Pankaj Sharma1 ,Nimisha2
    1-M Pharm (Pharmaceutics) , Amity Univerity,Lucknow
    2-Lecturer,
    Amity University,
    Lucknow

    Abstract:
    Rapid developments in the field of molecular biology and gene technology resulted in generation of many macromolecular drugs including peptides, proteins, polysaccharides and nucleic acids in great number possessing superior  pharmacological efficacy with site specificity and devoid of unwanted and toxic effects. However, the main impediment for the oral delivery of these drugs as potential therapeutic agents is their extensive presystemic metabolism, instability  in acidic environment resulting into inadequate and erratic oral absorption. Parentral route of administration is the only  established route that overcomes all these drawbacks associated  with  these  orally  less/inefficient  drugs  but,  these   formulations  are  costly,  have  least  patient compliance, require repeated administration, in addition to the other hazardous effects associated with this route. Buccal drug delivery leads direct access to the systemic circulation through the internal jugular vein bypasses drugs from the hepatic first pass metabolism leading to high bioavailability. Buccal route is an attractive route of administration for systemic drug delivery. Buccal bioadhesive films, releasing topical drugs in the oral cavity at a slow and predetermined rate, provide distinct advantages over traditional dosage forms for treatment of many diseases.

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