Pharmaceutica Analytica Acta

A proposed preliminary study of a novel combination of Metformin and vitamins as oral tablets

5^th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems

March 16-18, 2015 Crowne Plaza, Dubai, UAE

Abdul-Rahman A AL-Bazzaz and Israa Al-Ani

Posters & Accepted Abstracts: Pharm Anal Acta

Abstract:

Metformin is one of the leading oral hypoglycemic drugs, which is one of the top prescribed medications in the US and our countries for mostly for Type- II diabetes. But, one of its side effects is to decrease plasma folate and vitamin B12 levels which are very important vitamins for the metabolism of the non- essential amino acid known as homocysteine (Hys) leading to increase its plasma level. Elevated Hys levels have now been correlated with a wide array of illnesses, including diabetes, heart disease, stroke, neural tube defects, osteoporosis, depression, schizophrenia, macular degeneration, cervical cancer, and birth defects. Recent studies have implicated that high levels of Hys is an additional risk which may contribute to the development of cardiovascular diseases. Measuring and treating diabetic patients for elevated Hys may increase the benefit of improving glycemic control decreasing the complications of diabetes. To get rid of metformin side effect on vitamins absorption, we propose a novel combination therapy (metformin+ vitamins) in one tablet where those vitamins are already marketed as oral dosage form in the daily requirements approved by WHO and FDA. The suggested dosage form that contains a combination of metformin with vitamin B12, B6, B1 and folic acid in immediate release bilayered tablet. One layer contain vitamins while the second layer contains 850mg metformin. Other approach is to give the above vitamins mixture with sustained release 1000 mg metformin by using bilayer tablet. One layer is an immediate release which contains half the amount of the vitamins combination for one day. The second layer is sustained released that contains 1000mg of metformin to be released over 12 hours. This would help taking the required vitamins as well as preserving stable level of metformin to control blood glucose. The suggested type of sustained release layer is matrix tablet which contains hydrophilic insoluble matrix like hydroxypropyl methyl cellulose in specified ratios with hydrophilic polymer like microcrystalline cellulose. Compatibility of all ingredients with active constituents is to be studied as well as all factors that should be optimized for successful tablet dosage form. This novel combination has the advantage of controlling level of homocysteine in the patient?s body in addition to maximum patient compliance by avoiding administration of multiple tablets which may be of uncontrolled levels of vitamins. This new formula is to be tested on a statistically relevant number type I diabetic patients in cooperation with a diabetes center were the level of homocysteine and the vitamins supplied will be measured periodically to evaluate the efficiency of the dosage form. All studied would be carried according to the FDA rules and protocols.