[Formulation of tablets decreasing plasma homocysteine levels].
Clinical studies confirm that intake of folate, vitamin B6 and B12 above the current recommended dietary allowance is of great significance in the primary prevention of coronary heart disease. In order to fulfill the ever increasing requirements concerning the external appearance, reproducible production of medicines and to decrease the time necessary for the preformulation and formulation experiments, I selected methods which enabled rational experimental design and fast objective evaluation. The objective of my thesis was to formulate tablets containing folic acid, vitamin B6 and B12 of optimal therapeutic concentration and of required stability in the presence of novel excipients applied in direct compression. In the course of my preformulation work thermoanalytical (DTG, DSC), chromatographic (HPLC) and spectrometric (NIR) methods were applied. Destabilizing interactions were evaluated with directly compressible excipients, like Ac-Di-Sol, Cellactose, Tablettose, Avicel PH101, Ludipress. Interactions were detected in the 1 + 1 physical mixtures of vitamins and excipients containing lactose (Cellactose, Ludipress, Tablettose) and their destabilizing effect was confirmed. The results of preformulation studies enabled detection of drug-excipients interactions and selection of compatible excipient system to the given drug composition to formulate dosage form of required stability, processability and effectiveness.
Semmelweis Egyetem, Gyógyszerészeti Intézet, Budapest, Hógyes Endre u. 7.-1092.
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Budavári
D002482:Cellulose; D005492:Folic Acid / Q000627:therapeutic use*; D006710:Homocysteine / Q000037:antagonists & inhibitors* / Q000097:blood*; D006801:Humans; D015203:Reproducibility of Results; D013607:Tablets; D014805:Vitamin B 12 / Q000627:therapeutic use*; D025101:Vitamin B 6 / Q000627:therapeutic use*
D013607:Tablets; D006710:Homocysteine; D025101:Vitamin B 6; D002482:Cellulose; D005492:Folic Acid; D014805:Vitamin B 12