A new self-microemulsifying mouth dissolving film to improve the oral bioavailability of poorly water soluble drugs. (September 2013)

• Record Type: Journal Article
• Authors: Xiao, Lu; Yi, Tao; Liu, Ying
• Is Part Of: Drug development and industrial pharmacy. Volume 39:Number 9(2013:Sep.)
• Page Start: 1284
• Page End: 1290
• Publication Date: 2013-09
• Subjects: Self-microemulsifying -- mouth dissolving film -- poorly water-soluble drugs -- indomethacin -- bioavailability; Pharmaceutical chemistry -- Periodicals; Pharmaceutical industry -- Periodicals; Drug Industry -- Periodicals; Technology, Pharmaceutical -- Periodicals; 615.05
• DOI: 10.3109/03639045.2012.723716
• Languages: English
• ISSNs: 0363-9045

Abstract

Abstract : A new self-microemulsifying mouth dissolving film (SMMDF) for poorly water-soluble drugs such as indomethacin was developed by incorporating self-microemulsifying components with solid carriers mainly containing microcrystalline cellulose, low-substituted hydroxypropyl cellulose and hypromellose. The uniformity of dosage units of the preparation was acceptable according to the criteria of Chinese Pharmacopoeia 2010. The SMMDF was disintegrated within 20 s after immersion into water, released completely at 5 min in the dissolution medium and achieved microemulsion particle size of 28.81 ± 3.26 nm, which was similar to that of liquid self- microemulsifying drug delivery system (SMEDDS). Solid state characterization of the SMMDF was performed by SEM, DSC and X-ray powder diffraction. Results demonstrated that indomethacin in the SMMDF was in the amorphous state, which might be due to self-microemulsifying ingredients. Pharmacokinetic parameters in rats including T max, C max, AUC were similar between the SMMDF and liquid SMEDDS. AUC and C max from the SMMDF were significantly higher than those from the common mouth dissolving film or the conventional tablet, and T max from SMMDF group was also significantly decreased. These findings suggest that the SMMDF is a new promising dosage form, showing notable characteristics of convenience, quick onset of action and enhanced oral bioavailability of poorly water-soluble drugs.