“FORMULATION DEVELOPMENT AND STABILITY STUDIES OF VITAMIN D3: COMPARISON AMONG DIFFERENT PREPARATION METHODS”
DISSERTATION PROTOCOL
SUBMITTED TO RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE.
BY VENKATRAO MANNAM M.PHARM, PART-I DEPARTMENT OF PHARMACEUTICS NARGUND COLLEGE OF PHARMACY BANGALORE-85 (2010-2012) RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR P.G DISSERTATION
1. NAME OF THE CANDIDATE VENKATRAO MANNAM AND ADDRESS NARGUND COLLEGE OF PHARMACY, DATTATREYA NAGAR, II MAIN, 100 FEET RING ROAD, BSK III STAGE, BANGALORE-85, KARNATAKA.
2. NAME OF THE INSTITUTION NARGUND COLLEGE OF PHARMACY, DATTATREYA NAGAR, II MAIN, 100 FEET RING ROAD, BSK III STAGE, BANGLORE-85, KARNATAKA.
3. COURSE OF STUDY AND MASTER OF PHARMACY IN SUBJECT PHARMACEUTICS
4. DATE OF ADMISSION OF 3rd APRIL 2010. COURSE
“ FORMULATION DEVELOPMENT AND 5. TITLE OF TOPIC STABILITY STUDIES OF VITAMIN D3: COMPARISON AMONG DIFFERENT PREPARATION METHODS ” 6. BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
Vitamin D is also called the Antirachitic vitamin, as it counteracts rickets, breaking- down of the mineral substance in fully grown bones (Osteodistrophy), bone and joint deformations, growth disorders, spontaneous brittleness of bones and deficient eggshell strength. The term vitamin D actually refers to a pair of biologically inactive precursors of a
critical micronutrient. They are vitamin D3, also known as Choleacalciferol, and vitamin
D2 also known as Ergocalciferol. Choleacalciferol (D3) is produced in the skin by a photoreaction on exposure to UV light from the sun (wavelength 290 to 320nm).
Ergocalciferol (D2) is produced in plants and enters human diet through consumption of
plant sources. D2 and D3 forms are inactive as such but once present in the circulation,
enter the liver and kidneys where they are hydroxylated to form active forms of D2 and
D3. D2 has shorter half life than D3.
Vitamin D3 plays an important part in human and animal nutrition. It regulates the absorption, metabolism and excretion of calcium and phosphorus from the intestine and kidneys. Further it controls the incorporation of calcium and phosphorus in the skeleton. It is common to this fat-soluble agent that, in its pure form, it can be handled only with difficulty or not at all, because it is oxidation-sensitive substance. Furthermore, a fine dispersion of the agent is advantageous for optimal absorbability and thus bioavailability. These substances are therefore often supplied in the form of emulsions or in the dry powders or as solution in physiologically tolerated oil or embedded in a fine dispersion in a protective colloid. All of these methods have common drawbacks such as rapid deformation and disintegration due to heat or physical force and also due to aqueous solution employed. Decreased content uniformity increased running cost as decreased productive are the other disadvantages. Recently soft capsules containing a
vegetable oil solution of active vitamins D3 have also developed. However, soft capsules have their particular drawbacks such as that are limited in their form and that the process of their preparation is complicated. So an attempt will be made to produce an efficient formulation of granule or powder forms which will be stable throughout its shelf life, dispersible in aqueous solutions and overcome the above mentioned draw backs.
Powdering or granulating of vitamin D3 can be accomplished by any or all of the 9. SIGNATURE OF THE CANDIDATE
( VENKATRAO MANNAM ) 10. REMARKS OF THE GUIDE RECOMMENDED FOR DISSERTATION WORK.
11. NAME & DESIGNATION OF
11.1 GUIDE Dr. GOPAL MURALIDHARAN PROFESSOR DEPT.OF PHARMACEUTICS NARGUND COLLEGE OF PHARMACY
11.2 SIGNATURE
11.3 HEAD OF THE Dr. C.S.R. LAKSHMI DEPARTMENT PROFESSOR HEAD OF THE DEPARTMENT OF PHARMACEUTICS NARGUND COLLEGE OF PHARMACY
11.4 SIGNATURE
12. 12.1 REMARKS OF THE FORWARDED AND PRINCIPAL RECOMMENDED FOR FAVORABLE CONSIDERATION.
Prof. DAYANAND. S. PURANIK PRINCIPAL
12.2 SIGNATURE.