Pharmaceutics Articles

COMPARATIVE STUDY OF DRUG PRODUCT RECALL REGULATIONS IN USA, UK AND AUSTRALIA AND DRAFT GUIDELINES FOR INDIA

About Authors: 
Bane Singh Rajput*
Research Scholar of Lachoo Memorial College of Science & Technology
Pharmacy Wing, Jodhpur (Raj.)
*bnsingh29@gmail.com

Abstract
Drug product recall is an action taken to withdraw or remove a batch or an entire production run of a drug product from distribution or use and return them to the manufacturer. It is usually done due to the discovery of deficiencies in quality, efficacy or safety in the marketed drug products. Defective drug products related to quality includes adulterated or spurious drugs. Safety and efficacy related recalls include serious adverse reactions and death. Recalls also include drugs prohibited under the law and also those products for which product licenses are suspended/ cancelled. In USA, guidelines for drug product recall are described under 21 CFR Parts 7, 107 and 1270.  In Australia, guidelines for drug product recall are described under section 65F of the Trade Practices Act 1974. Sections 2(2), 4, 5 and 7 of the European Communities Act 1972 and Directive 2001/95/EC on general product safety are followed in UK for drug product recall. In India, references for drug product recalls, complaint and adverse reactions are mentioned in Para 27, 28 of Schedule M and conditions of license for defective product recall in Rule 74(j) and Rule 78(i) of the Drugs and Cosmetics Act, 1940 and Rules there under. But no effective and uniform recall procedure and guidelines are formulated yet in India. This paper presents a comparative study of drug product recall guidelines in USA, UK and Australia. Based on this comparative study suggestions are provided to develop regulatory guidelines for drug product recall in India.


SURFACTANTS AND ITS APPLICATION IN PHARMACEUTICALS: AN OVERVIEW

About Author:
Dhananjay S Jadhav*
M.Tech (Pharmaceutical Technology), Division of Pharmaceutical Technology,
Institute of Chemical Technology, North Maharashtra University, Jalgaon -425001.
Maharashtra, India
* dhananjaysjadhav@hotmail.com

Abstract
Recently, surfactants have become one of the most important chemical products. They have become a subject of research, and their production and their use are on the increase. This wide range of properties, uses for surfactants in pharmaceutical products and systems is to try and introduce and explain in the subject of this article. Wetting of Solids, Solubilization, Emulsification, Dispersion of solid in solution, Micellization & Detergency all these are properties of surfactant. Surfactants are classified according to their polar head group, the charged head referred as Ionic surfactants and uncharged surfactants are generally referred to as nonionic surfactant. Because of their unique functional properties, surfactants find a wide range of uses in pharmaceutical preparations. These include, depending on the type of product, improving the solubility or stability of a drug in a liquid preparation, stabilizing and modifying the texture of a semisolid preparation, or altering the flow properties of a granulate, thus aiding in the processing of the final tablet dosage form. In addition to their use as excipients to improve the physical and chemical characteristics of the formulation, surfactants may be included to improve the efficacy or bioperformance of the product. The properties of surfactants are such that they can alter the thermodynamic activity, solubility, diffusion, disintegration, and dissolution rate of a drug. Each of these parameters influences the rate and extent of drug absorption. Furthermore, surfactants can exert direct effects on biological membranes thus altering drug transport across the membrane. The overall effect of inclusion of a surfactant in a pharmaceutical formulation is complex and may be beyond those initially intended. Surfactants may reduce the effectiveness of antimicrobials or preservatives included in a formulation.


DESIGN, DEVELOPMENT AND FUTURE APPLICATION OF MICROSPHERES

About Authors:
Divya Rawat, U.K.Singh, Faizi Muzaffar
Kharvel Subharti College of Pharmacy,
swami Vivekanand subharti university, Subhartipuram,
N.H-58, Meerut By Pass Road, Meerut, Uttar Pardesh-250001, India
*drawat05@gmail.com

Abstract
Microspheres constitute an important part of novel drug delivery system by virtue of their small size and efficient carrier capacity. Microspheres are characteristically free flowing powders consisting of proteins or synthetic polymers having a particle size ranging from 1-1000 μm. The range of Techniques for the preparation of microspheres offers a Variety of opportunities to control aspects of drug administration and enhance the therapeutic efficacy of a given drug. There are various approaches in delivering a therapeutic substance to the target site in a sustained controlled release fashion. One such approach is using microspheres as carriers for drugs also known as micro particles. It is the reliable means to deliver the drug to the target site with specificity, if modified, and to maintain the desired concentration at the site of interest. Microspheres received much attention not only for prolonged release, but also for targeting of anticancer drugs. The purpose of the review is to compile various types of microspheres, different methods to preparation, its applications and also various parameters to evaluate their efficiency.


ORAL DELIVERY OF INSULIN AND ITS CURRENT STATUS

About Authors:
Kritika Rastogi, U.K. Singh, A.K. Chaturvedi
Kharvel Subharti College of Pharmacy, (swami vivekanand subharti university) subhartipuram,
N.H-58, Meerut By Pass Road, Meerut, Uttar pradesh-250001,India.
*kritikarastogi6@gmail.com

Abstract
Insulin remains the most effective and durable hypoglycemic agent for the treatment of diabetes. Insulin is a major protein hormone secreted by beta –cells of the pancreas and is important for the control of diabetes. Insulin has an important place in drug therapies for insulin dependent diabetes mellitus (type I) and for many patients with non-insulin-dependent diabetes mellitus (type II). It would be highly advantageous if insulin could be administered orally, because the oral delivery of insulin can mimic the physiological fate of insulin and may provide better glucose homeostasis. The desire to deliver protein and peptide biopharmaceuticals conveniently and effectively has led to the intense investigation of targeted delivery systems. The goal of oral insulin delivery devices is to protect the sensitive drug from proteolytic degradation in the stomach and upper portion of the small intestine.


USE OF NATURAL SUPERDISINTEGRANT IN MOUTH DISSOLVING TABLET

ABOUT AUTHORS:
Mr. Kulkarni Sarang*,Birajdar Shivprasad M., Shaikh Parvej H., Dr. Poul B.N
Maharashtra College of Pharmacy, Nilanga, dist. Latur (MS) 413521, India
*sarangkulkarni342@gmail.com

ABSTRACT
Oral route is the most preferred route for administration of various drugs because it is regarded as safest, most convenient and economical route. Recently researcher developed the fast disintegrating tablets with improved patient compliance and convenience. Fast disintegrating tablets are solid dosage forms which dissolve rapidly in saliva without chewing and additional water. Fast disintegrating tablets overcome the disadvantages of conventional dosage form especially dysphagia (difficulty in swallowing) in paediatric and geriatric patients. Natural materials have advantages over synthetic ones since they are chemically inert, nontoxic, less expensive, biodegradable and widely available. They can also be modified in different ways to obtain tailor- made materials for drug delivery systems and thus can compete with the available synthetic excipients. With the increasing interest in polymers of natural origin, the pharmaceutical world has compliance to use most of them in their formulations. The natural superdisintegrants can be used instead of synthetic superdisintegrants as they showed equal disintegrating property as that of synthetic agents or dispersible tablets.


A REVIEW ON MOUTH DISSOLVING TABLETS

About Authors:
Chandan bisht1*, Dr.Jagannath sahoo2, Dr.M.Irfan Khan3
1,2 Shri Ram Murti Smarak college of Eng. & Tech( department of pharmacy) Bareilly.
3 Deccan Healthcare pvt. Ltd. Pantnagar industrial area
*chandanbisht2011@gmail.com

Abstract:
Mouth dissolving tablets (MDT) are useful in patients, such as pediatric, geriatric, bedridden, or developmentally disabled, who may face difficulty in swallowing conventional tablets or capsules and liquid orals or syrup, leading to ineffective therapy, with persistent nausea, sudden episodes of allergic attack, or coughing for those who have an active life style. Over the past three decades, mouth dissolving tablets have gained considerable attention as a preferred alternative to conventional tablets and capsules due to better patient compliance The objective of this article is to review the development of MDTs, challenges in formulation,  benefit, limitation ,new MDT technologies and evaluation methodologies.


PULMONARY DRUG DELIVERY: A REVIEW

ABOUT AUTHORS:
Dr. N.V. Satheesh Madhav, Girish Dwivedi*
Dehradun Institute of Technology, Faculty of Pharmacy
Village Makkawala, Mussoorie Diversion Road,
Dehradun-248009

*Girish10.dwivedi@yahoo.com

ABSTRACT
Pulmonary route of drug delivery gaining much importance in the present day research field as it enables to target the drug delivery directly to lung both for site specific and systemic treatment. The review is prepared with an aim to discuss about the technical, physiological, and efficacy aspects of the novel pulmonary route of drug targeting and different delivery devices such as metered dose inhalers (MDI), dry powder inhalers (DPI), nebulizers, etc. The review also focuses on the mechanisms of pulmonary drug administration along with compatibility of the excipients employed, devices used, techniques of particulate dosage production, evaluation and advancements in the pulmonary drug delivery. It can be concluded from whole study that different pulmonary delivery system possesses certain specificity for dosage formulations and serves as an important tool to deliver drugs to the target site.


REGULATORY ISSUES AND NATURAL PRODUCTS

About Authors:
Sapna Phadtare,* Vaibhav Shinde, Kakasaheb Mahadik
Department of Pharmacognosy, Poona College of Pharmacy,
Bharati Vidyapeeth University, Erandwane,
Maharashtra, Pune-411038
*sapnaphadtare@gmail.com

Abstract
The world is gifted with wonderful and precious resources such as plants, animals and minerals that form the major part of our medical system. We as humans are so dependent on these natural sources that life without them is beyond imagination. Thus it is of prime importance that we look into the conservation and preservation of natural products. The Indian and international government bodies have developed various laws, rules and conventions to ensure sustainability of such natural products. This article reviews the general laws, rules and regulations developed globally for natural and traditional medicine. Various guidelines like WHO, EMEA, TGA guidelines are looked upon. Some difficulties that are faced regarding regulatory issues of herbal medicines are studied. The Acts like Indian patent Act, Plant Variety Protection Act, Farmer’s rights, terms like Biodiversity and Biopiracy are reviewed in this article.


DRAFTING OF PATENT CLAIMS AND NONOBVIOUSNESS IN PATENT

ABOUT AUTHORS:
Mohit kumar*, Vishal Sachdeva,
Seth G. L. Bihani S. D. College of Technical Education,
Sri Ganganagar (RAJASTHAN) 335001, INDIA
*mohigarg30@gmail.com

ABSTRACT
A well drafted application decides the fate of an invention. Drafting plays a vital role in the success of an invention during its prosecution, management and maintenance during its tenure and turning it into cash. Drafting a patent application is one of the most important and at the same time one of the most difficult process. The applicant or his agent should so draft a patent application that it is granted with an adequate scope or ambit so as to fully serve the business purpose(s) for which the patent is meant to be used. It is here that the importance of drafting the claims in a patent must be fully appreciated, as the drafting of claims must always be done with a clear focus on the exact business needs that are sought to be served by it. That is, a business strategy perspective must inform the thinking of the one who takes up the task of drafting the patent claims. The ultimate purpose of every business strategy is to ensure that a business makes the desired amount of profit to justify the risks taken in making the investments of resources and time. Similarly, the purpose of drafting claims should be to fully serve the business strategy at hand. Even so, only a small number of well drafted patents are actually used by businesses to help them to make or safeguard their profits. (Swarbrick James, 2007).


REVIEW - QUALITY CONTROL OF PARENTERAL PRODUCTS

About Authors:
Abhijeet Welankiwar*, Sushant Tope
Government college of pharmacy Amravati
Kathora naka, amravati (maharashtra) 44460

*abhi123welankiwar@gmail.com

ABSTRACT:
In a pharmaceutical organization a quality control is a fundamental segment that refers to a process of striving to produce a product by a series of measures requiring an organized effort by entire company to eliminate or prevent error at any stage of production. Quality control deals with testing, sampling, specification, documentation, release procedure which ensure that all tests are actually carried out prior to release of material for sale or use. Until its quality judged to satisfactory. This article deals with quality control of parenteral preparation which have 4 basic area that are Sterility, Freedom form Pyrogens, Freedom from particulate matter and leakers. It gives details on each of these 4 Basic areas. The achievement of sterile, non pyrogenic and particulate free parenteral product provides a significant challenge to ingenuity and creativity of parenteral scientist and technologist.


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