US FDA Approves first biodegradable sealant patch for Cardiovascular Surgery

The United States FDA approved first biodegradable sealant patch for Cardiovascular Surgery , TachoSil the biodegradable sealant patch  manufactured by Nycomed Austria GmbH of Linz, Austria , is  a first of its kind and is a absorbable fibrin sealant patch which can be used in cardiovascular surgery to stop mild and moderate bleeding from small blood vessels, when standard surgical techniques are not viable or are unsuccessful , This Blood clotting patch is absorbed by the body after the cut  is healed completely.

TachoSil is a ready for use surgical patch which consists dry collagen sponge made from horse tendons, which are coated with fibrinogen and thrombin.
Hemostasis is achived with the help of clot formation over cut by fibrin mesh , fibrin is a fibrous protein which is formed from fibrinogen , in presence of thrombin and other factors responsible for blood clotting, fibrin polymerizes to form almost enough thick mesh to prevent bleeding,

Thrombin is a procoagulant , Thrombin cleaves fibrinogen to fibrin , it activates coagulation factors V, VIII and factor XI which helps prevents fibrin clots from undergoing heamolysis , and helps to maintains homeostasis .
The TachoSil a biodegradable patch breaks down inside the body in four to six months. TachoSil is not intended for use within blood vessels.
This will help to control mild and moderate bleeding from blood vessels during cardiovascular surgery when standard surgical techniques are ineffective or impractical

The plasma which is used to produce TachoSil is collected from U.S. donors who are screened and tested for diseases transmitted by blood. The fibrinogen and thrombin required to produce TachoSil the surgical patch are subjected to additional manufacturing processes to remove impurities, including bloodborne viruses. The collagen required to produce TachoSil is derived from horse tendons is subjected to steps to remove impurities, including equine viruses.

The efficiency of TachoSil manufactured by Nycomed Austria GmbH of Linz, Austria was evaluated in a Clinical Trial of 119 cardiovascular surgery patients.
Bleeding was reported to be stopped within three minutes (74.6 percent) of those who received TachoSil ,compared with 33.3 percent in the control group.

Hypersensitivity to product components or allergic reactions may occur with TachoSil. The adverse reaction rates were not statistically different between the study and control groups.

Hence the patient who is going to receive the biodegradable sealant Patch may be required to be tested for allergic reactions.

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 ValidationTypes of validations in pharmaceutical manufacturing

Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coeeficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Eletronic record in pharmaceutical manufacturing industry

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 company 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