Formulation, Evaluation, and Characterization of Ibuprofen Nanocrystals Tablets with Conventional Market Product.

The objective of this study was to prepare and evaluate ibuprofen nanocrystals using isopropyl alcohol and stabilizer sodium lauryl sulphate by way of the precipitation method. The nanocrystals were prepared by the bottom-up approach of the precipitation technique. This technique involves the use of an organic phase, which is completely miscible in the external aqueous phase. The ratio used for organic solvent-to-aqueous solvent was 1:50. The Fourier Transform Infrared Spectroscopy analyses confirmed that the drug and excipients were compatible, and the differential scanning calorimetry results indicated that the precipitation method led to no change in the crystalline structure of the drug. Scanning electron microscopy analysis of ibuprofen nanocrystals showed the promising size reduction of pure drug ibuprofen. Differential light scattering technique showed significant decrease in particle size and good stability of ibuprofen nanocrystals. Ibuprofen nanocrystals increased 20% to 25% of the saturation solubility of ibuprofen nanocrystals. Ibuprofen nanocrystals showed 90% drug release in the dissolution medium within 1 hour, while the pure drug and market product were dissolved only up to 58% and 63%, respectively. Ibuprofen nanocrystals increased the saturation solubility and in vitro dissolution of the drug as compared to conventional market product.

Design and Development of Agglomerated Isomalt.

The objective of this study was to prepare agglomerated isomalt by using the melt granulation process. This method involved the use of 99.5% of isomalt with the meltable binder glyceryl monostearate in a concentration of 0.5%. Glyceryl monostearate has a melting point of 50°C to 55°C, therefore, glyceryl monostearate was melted at its melting point and isomalt powder was blended with it to break the mass into agglomerates. The agglomerates were cooled to room temperature and were then screened to obtain granules of the desired size. The Fourier Transform Infrared Spectroscopy studies confirmed that the chemical structure of isomalt was not changed before and after the melt granulation process. A differential scanning calorimetry study showed that there was no appearance of more new peaks or disappearance of  one or more peaks corresponding to those of the isomalt powder and agglomerated isomalt, which showed no changes in the structure of the isomalt powder before and after the agglomeration process. The agglomerated isomalt and galenIQ 721 showed almost identical solubility profiles for g of solute per 100 g of solution at different temperatures. The scanning electron microscopy analysis of agglomerated isomalt showed promising results for the preparation of agglomerates of isomalt with glyceryl monostearate. The flow properties of the agglomerated isomalt compared with the galenIQ 721 and pure isomalt powder and melt granulation process showed promising results for agglomerated isomalt. The melt granulation process showed promising results to prepare agglomerates of the isomalt with the meltable binder glyceryl monostearate.