Saturday, October 29, 2011

ICT with DPST & UGC-CAS to organise 2-day symposia on nanomedicine


Institute of Chemical Technology (ICT), Mumbai in collaboration with the Department of Pharmaceutical Sciences and Technology (DPST) and the UGC Centre of Advanced Studies (UGC-CAS) is organising a two day Indo-US joint symposia on nanomedicine: Its prospects and challenges from November 14 – 15, 2011 at ICT campus.

Nanomedicine, is a concept originated from India. In Ayurveda, the use of Bhasmas is still popular which is a form of nanomedicine. The modern medicine has realized the potential of nanomedicine to reduce the dose, toxicity and for its targeting potential worldwide.

The nanomedicine is used for diagnostics and therapeutics of cancer, neurodegeneratives, tuberculosis, malaria and other infectious diseases is established and a thrust area of research. Many nanotechnology products based on immunomodulator formulations are in clinical use.

Prof Vandana B Patravale, professor of pharmaceutics, DPST and ICT, Mumbai said that this will be the first time where India and US will come together and this collaboration is expected to foster between the US and Indian investigators and it will be academia-academia, industry-industry collaboration.

“It will be beneficial for Indian consumers as the high end technologies could be identified with drug delivery systems, and devices. This could be the key feature to drive growth of pharmaceutical and medical sectors into cost effective, patient compliant, safe yet superior products for Indian market,” further she added.

This symposia will target biomedical engineers, pharmaceutical and clinical researchers, clinicians as well as graduate and post doctorate fellows and research scientists from both academia and industry who have an interest in nanomedicine and its potential to improve patient care.

source: Pharmabiz

Monday, October 10, 2011

Merck's combo pill Juvisync gets US FDA nod


Merck & Co. have announced that the US FDA have approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.

Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body's own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Simvastatin is an HMG-CoA reductase inhibitor, or statin, approved for use with diet and exercise to reduce the amount of "bad cholesterol" (low-density lipoprotein cholesterol or LDL-C) in the blood.

This FDC is based on substantial experience with both sitagliptin and simvastatin, and the ability of the single tablet to deliver similar amounts of the drugs to the bloodstream as when sitagliptin and simvastatin are taken separately. Juvisync is a convenience combination and should only be prescribed when it is appropriate for a patient to be placed on both of these drugs.

Juvisync was approved in dosage strengths for sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. The company have committed to develop FDC tablets with the sitagliptin 50 mg dose, as Juvisync 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg. Pending availability of the FDC tablets containing 50 mg of sitagliptin, patients who require this dose should continue to use the single ingredient sitagliptin tablet. There is no plan to develop FDCs with the sitagliptin 25 mg dose as use of this dose is quite low.

Simvastatin is currently marketed in dosage strengths of 5, 10, 20, 40, and 80 mg. Due to recent restrictions placed on the use of the 80 mg dose because of a higher risk of muscle toxicity, there will not be a FDC using this dose. Merck does not plan to develop FDCs with the simvastatin 5 mg dose as use of this dose is quite low as well. 

Click here to read the approval letter.