Abstract
Objective: The objective of the study was to evaluate Ocimum gratissimum mucilage as a novel superdisintegrant in the formulation of fast-dissolving tablets (FDT) of Biopharmaceutical Classification System-II drug (Ibuprofen) employing a 23 factorial design.
 Methods: O. gratissimum mucilage was extracted by seeds and it was subjected to physical, chemical, and micrometric studies were evaluated. To establish FDT of ibuprofen with O. gratissimum mucilage as a superdisintegrants in different ratios using direct compression method employing 23 factorial design. All the formulation tablets were evaluated pre-compression and post-compression parameters like dissolution efficiency (DE%) percent of drug dissolved at 5 min.
 Results: The mucilage was to be found fine, free-flowing crystalline powder, and excellent swelling nature in all suitable solvents and buffers. The Fourier transform infrared and differential scanning calorimetry studies were indicated to no interactions between ibuprofen and O. gratissimum mucilage. All the FDT formulated employing novel mucilage shows good quality with regard drug content (98.05±0.31–99.39±0.54), hardness (3.6– 4 kg/sq. cm), and friability (0.12–0.15%). The optimized formulation batch shows less disintegrant time (30±0.06). In vitro wetting time was less (i.e., 90 s) in optimized formulation F2. The water absorption ratio of the formulated tablets was found to be in the range of 99±0.56. The cumulative drug dissolved in the optimized formulation F2 was found to be 99% in 10 min.
 Conclusion: O. gratissimum mucilage was found to be a novel superdisintegrant which enhanced the DE when combined with crospovidone and croscarmellose sodium; hence, it could be used in the formulation of FDT to provide immediate release of the contained drug within 5 min.
Highlights
Oral routes of drug administration have a wide acceptance of up to 50–60% of the total dosage form
Natural novel mucilage was found to be a superdisintegrant which enhanced the dissolution efficiency (DE) when combined with crospovidone and croscarmellose sodium, with the ibuprofen and it could be used in the formulation of fast-dissolving tablets (FDT) to provide immediate release of the contained drug within 1 min
That is, amount of X1 – amount of O. gratissimum, X2 – croscarmellose sodium, and X3 – crospovidone at three levels were selected on the basis of preliminary studies
Summary
Oral routes of drug administration have a wide acceptance of up to 50–60% of the total dosage form. Fast-dissolving tablets (FDTs) are solid dosage form containing indicated substances that disintegrate rapidly, usually within few seconds when placed on tongue requiring additional water to facilitate swallowing. Physiological and neurological conditions, such as dysphasia, a risk of choking, and hand tremors are leading causes of patient non-compliance in the self-administration of conventional solid oral dosage forms [1,2,3]. FDT formulation provides sufficient strength, quick disintegration/ dissolution in the mouth without water, rapid dissolution, and absorption of the drug, which will produce the quick onset of action. Direct compression one of the techniques which need for a particular purpose the inclusion of super disintegrate or highly water-soluble excipients into the formulation to reach fast tablet disintegration. Direct compression does not require the use of water or heat during the formulation procedure and is the ideal method for moisture and heat-liable medication
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