January 2016

PharmaTutor
4 January 2016

A REVIEW ON: PRESERVATIVES USED IN PHARMACEUTICALS AND IMPACTS ON HEALTH

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ABOUT AUTHORS
Sabir M. Shaikh*1, Rajendra C. Doijad1, Amol S. Shete1, Poournima S. Sankpal2
1 Department of Pharmaceutics, Shree Santkrupa College of Pharmacy, Ghogaon, Karad, Maharashtra, India.
2 Department of Pharmaceutical chemistry, Shree Santkrupa College of Pharmacy, Ghogaon, Karad, Maharashtra, India.
*sabirmshaikh17@gmail.com

ABSTRACT
For several decades pharmacist have been aware of the need to protect their products against microbial contamination but it is only during the last one or perhaps two decades the serious thought of has been applied to the science of preservation. Preservatives are commonly used as additives in pharmaceutical products, food and cosmetics. Some of the liquid preparation are susceptible to microbial contamination because of the nature of ingredients present in it. Such preparation are protected by preservatives which avoids degradation and alteration of the product.A preservative is a natural or synthetic chemical added to various products which helps to prevent microbial decomposition. Present article deals with the study of ideal properties, classification, mechanism of action, Pharmaceutical applications and its impact on health of various preservatives used in pharmaceuticals.

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Global Blood Therapeutics, Inc. (GBT), a biopharmaceutical company developing novel therapeutics for the treatment of grievous blood-based disorders with significant unmet needs, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for GBT440 for the treatment of patients with sickle cell disease (SCD). GBT440 is being developed as a potentially disease-modifying therapy for SCD.

PolyNovo has elaborated on an earlier U.S. Federal Food and Drug Administration approval for its regenerative medical device for use in reconstructive and surgical wounds.

The 510(k) approval allows PolyNovo to sell its device now in the U.S. surgical wound market which is estimated at US$800 million per annum.

This means that PolyNovo has approval for management of wounds including partial and full thickness wounds, pressure, venous and diabetic ulcers, surgical wounds, trauma wounds and abrasions and second-degree burns.

The FDA determined that PolyNovo's BTM is substantially equivalent for the indications above to predicate devices in the market.


However there is more to this than at first blush. PolyNovo has a distinguishing feature with its BTM device in dermal matrixes with trials to date showing outcomes with significantly improved functional and cosmetic outcomes.

Reimbursement of the dermal matrixes in hospitals and alternate care facilities is an established process with prices established on a surface area and application basis.


This paves the way for PolyNovo to pursue and open negotiations with multi-national wound companies for the U.S. distribution rights while PolyNovo retains manufacturing of the finished product.

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Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company focused on the development of therapies to treat CNS disorders, announced that the US Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for MIN-101, a first-in-class 5-HT2a and sigma2 antagonist in clinical development for the treatment of schizophrenia.

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