Formulation and evaluation of immediate release folic acid tablets

摘要

Among the different routes of administration, the oral route of administration continues to be the most preferred route due to various advantages including ease of ingestion, avoidance of pain, versatility and most importantly patient compliance. The different dosage forms include tablets and capsules. Recently immediate release tablets have started gaining popularity and acceptance as a drug delivery system, mainly because they are easy to administer and lead to better patient compliance. They are also a tool for expanding markets, extending product life cycles and generating opportunities. An overage is fixed amount of drug added to the formulation in excess of label claim. The present work involves the formulation development, optimization and in-vitro evaluation of immediate release Folic Acid tablets. To minimize critical process parameters and since folic acid is moisture and heat sensitive, direct compression method was selected for the formulation of immediate release Folic Acid tablets. Tablets were prepared containing 40% overages using cross carmellose sodium, crosspovidone, pre gelatinized starch and sodium starch glycolate as disintegrants since tablets containing 10% overages failed to meet the desired specifications. During the course of study it was found that the formula G8 containing pregelatinized starch as disintegrant exhibited acceptable disintegration time, percentage drug content per tablet and in vitro drug release. So at last it was concluded that immediate release folic acid tablets containing 40% overages can be prepared using direct compression which met the required specifications.