Custom Search

Monday, March 29, 2010

US FDA ask's pharmaceutical manufacturers to stop marketing Unapproved Nitroglycerin tablets

US FDA has officially asked pharmaceutical manufacturers to stop selling nitroglycerin tablets which are not approved by US FDA.
US FDA has asked these pharmaceutical manufacturers to stop the production of nitroglycerin tablets which are not approved by US FDA, with in 90 days , and they can ship the available stock with in six months .

US FDA says safety of these unapproved products is not known , though the formulations were in sale for long time , FDA says it is required to be assured that the products are safe , the exeipients , impurities , labeling of product , and clinical study data is required to be evaluated by US FDA in order to declare that the product is safe for use. Safety of a drug is automatically conferred once the US FDA approves the product for sale .
These pharmaceutical companies were able to sale their products to because of the rule for drugs whos use predates the date of establishment FDA 1938 .
Nitroglycerin tablets are sublingual dosage form , as these tablets are placed under tongue , and the drug is absorbed rapidly in to vein under tongue and drug is made available to heart ,the absorption if fast ,and is most effective in case of angina pectoris and other congestive heart disease attacks, where the drug is a potent vasodilator , helps in reliving the congestion and facilitate blood circulation , and oxigen supply is increased, it improves availability of oxigen to heart muscles , it is a critical and life saving drug.Nitroglycerin tablets are marketed in 0.3 mg, 0.4 mg, and 0.6 mg dosages.

As of no the only US FDA approved nitroglycerin tablets are those of Pfizer Inc , FDA said that ,they do not anticipate any supply problems.

Nitroglycerin (1,2,3-glyceryl trinitrate )


Nitroglycerin is a molecule which is a nitrated compound of glycerin ,Glycerin is subjected to nitration reaction , under the nitrating mixture of conc sulfuric acid and nitric acid, in controlled condition of temperature.The process is very critical , Nitroglycerin is also has a explosive property hence is handled very carefully during manufacturing.

There other molecules like isosorbide dinitrate , and isosorbide mononitrate which are used as vasodialator in treatment of  congestive heart disease and angina .

Mode of action of nitroglycerin:
It is belived that nitroglycerin molecule releases NO through nitrite (NO2 −) which are responsible for vasodialation .

Following are some of articles which;will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs in pharmaceutical industry

Pharmaceutical Validation , types of validation in pharmaceutical manufacturing
http://whoguideline.blogspot.com/2010/03/validation-in-pharmaceutical.html

Requirements of documents for validation of sterilisation process

http://whoguideline.blogspot.com/2009/11/us-fdas-requirements-of-documentation.html

How to investigate OOS out of specification results
http://whoguideline.blogspot.com/2009/09/how-to-investigate-out-of-specification.html

Determination of Phenol coeeficient of a disinfectant
http://whoguideline.blogspot.com/2009/04/determination-of-phenol-coefficient.html

Sterility testing
http://whoguideline.blogspot.com/2009/04/sterility-testing-of-pharmaceuticals.html

Cleen Room Classification
http://whoguideline.blogspot.com/2010/02/clean-room-classification-aspects-of.html


Time limitations in sterile pharmaceuticals processing
http://whoguideline.blogspot.com/2010/02/time-limitations-in-aseptic-process.html

Aspects of validation of manufacturing process in sterile pharmaceuticals
http://whoguideline.blogspot.com/2010/02/aspects-of-validation-of-aseptic_26.html

Clinical Trials
http://whoguideline.blogspot.com/2010/03/clinical-trials-medical-research.html

Controling Pyrogens in injectable dosage forms
http://whoguideline.blogspot.com/2010/03/pyrogens-and-depyrogenation-process-in.html

Good manufacturing practice in pharmaceutical industry

Here is intresting article on world wide pharmaceutical companies
Pharmaceutical industry pharmaceutical industry

We are inviting our readers to participate in building knowledge base on this website by sharing actual experience and issues in pharmaceutical manufacturing and get them published over this website , and join our elite team of authors .
you can participate in interactive activity over this website by answering to questions asked by readers of this website.
Write us at submitearticles ( @ ) gmail.com

No comments:

Posted by: Martin

How to sucessfuly activate and receive our articles on pharmaceuticals by E-Mail

Dear readers if you wish to receive our articles on pharmaceutical automatically into your email Inbox , as and when we write a new article over this website, then follow these 3 simple steps.


1.You should write your Email ID in the box provided and push the subscribe butten


2.Enter the text code that we show you in a small new browser window after you enter your email ID.

3.Log in to your email and Cheke our verification email sent by "FEEDBURNER" , there you should verify the link we send you by email.




Enter your email address get our articles by email whenever this website is updated





Delivered by FeedBurner



Join the list of our readers from Universities ,Research and Development centers Pharmaceutical Companies from all over the world.











Pharma Research Regulatory Guidelines Website
Texas Dallas, TX 75211 US
Email: editor@pharmacistspharmajournal.org Website: http://pharmacistspharmajournal.org/
Copyright © 2008-2015 all rights reserve www.pharmacistspharmajournal.org