Abstract
Objective: The primary objective of the project was to formulate and evaluate hard capsule containing the solution of ibuprofen. It also included enhancement of solubility of ibuprofen in hydrophilic solvents to obtain a unit dose capsule acceptable for human consumption.
 Methods: Solution of ibuprofen was developed by the salt formation of partial drug using potassium hydroxide in PEG 600 and water. The solution was encapsulated in hard capsules with band sealing. The final formulation was evaluated for uniformity of weight, disintegration, drug content and stability. The dissolution profile was compared with that of available marketed tablets and softgels.
 Results: The capsules were evaluated and found compliant as per specifications mentioned in general monograph of capsules in IP 2014. The uniformity of weight of the batch of capsules was found to be 734.8 mg (±0.58). The disintegration time of these capsules was observed to be 4.45 min. The drug content was found to be 100.03% and the product is stable over three months of test period under room temperature as well as accelerated conditions. The dissolution profile showed that softgels take longer time to release the drug whereas marketed tablets showed a dissolution profile comparable with that of formulated capsules.
 Conclusion: The developed capsule is a unit dose of liquid containing solubilized ibuprofen delivering the drug directly into the gastrointestinal tract (GIT). These are newer solid oral dosage forms with higher patient compliance and ease in manufacturing. They require lesser steps and manufacturing area when compared to the manufacturing of compressed tablets.
Highlights
Ibuprofen is a commonly prescribed non-steroidal antiinflammatory drug (NSAID) [1, 2]
Ibuprofen is reported to cause gastric disturbances when administered orally [7, 8]. To minimize this gastric irritation, ibuprofen should be absorbed from the gastrointestinal tract (GIT) as quickly as possible [9]
Ibuprofen was procured from BASF company (Batch no.: IB1V1517), polyethlene glycol (PEG) 600 from Merck specialities Pvt
Summary
Ibuprofen is a commonly prescribed non-steroidal antiinflammatory drug (NSAID) [1, 2]. Ibuprofen is reported to cause gastric disturbances when administered orally [7, 8]. Formulation scientists are working on different methods to decrease the gastric disturbances due to the administration of solid oral dosage forms of ibuprofen. Coated tablets are compressed blend of drug and excipients with a film coating This process involves many steps and evaluation of many in-process quality control parameters. Any changes in particle size, compression pressure can directly lead to variation in the quality of manufactured tablets [23]. These tablets are slow in absorption when compared to administration of solubilized ibuprofen
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