title: Development of a novel bi-coated combination capsule containing mosapride and probiotics for irritable bowel syndrome.
abstract: The objective of this study was to develop a novel combination product containing mosapride and probiotics for the treatment of irritable bowel syndrome. Enteric-coated hard gelatin capsules containing probiotics were prepared to protect acid-labile probiotics from the stomach by spray coating with hydroxypropylmethylcellulose phthalate, and then coated with various hydrophilic polymer solutions containing mosapride. The influence of different hydrophilic polymers on the aqueous solubility and dissolution of sparingly soluble mosapride from the capsule was investigated to select the one which imparted highest solubility to mosapride in an aqueous solution. The physicochemical properties of the hydrophilic polymer coating were assessed using SEM and DSC. In addition, the bioavailability of the mosapride-coated capsule in beagle dog was evaluated and compared to that of conventional mosapride tablet (CMT). Based on DSC studies, the mosapride in polymer coating underwent amorphization or molecular dispersion. The enteric-capsule coated with mosapride/HPMC exhibited improved solubility of mosapride at acidic pH and showed significantly improved AUC (1.5-fold) and Cmax(1.6-fold) compared to the CMT. In conclusion, drug/polymer coated enteric gelatin capsule can be an alternative technique for co-delivery of sparingly water-soluble drug and acid-labile drug for enhanced solubility and bioavailability as well as for protection from acid degradation.
authors.affiliation: a College of Pharmacy, Yeungnam University , Gyeongsan , South Korea.|b Pharmaceutical Research Centre, Hanmi Pharm. Co. , Hwaseong, Gyeonggi-Do , South Korea , and.
authors.forename: Yong Il
authors.initials: YI
authors.lastname: Kim
authors.affiliation: a College of Pharmacy, Yeungnam University , Gyeongsan , South Korea.
authors.forename: Bijay Kumar
authors.initials: BK
authors.lastname: Poudel
authors.affiliation: a College of Pharmacy, Yeungnam University , Gyeongsan , South Korea.
authors.forename: Roshan
authors.initials: R
authors.lastname: Pradhan
authors.affiliation: c College of Pharmacy, Hanyang University , Ansan , South Korea.
authors.forename: Han-Gon
authors.initials: HG
authors.lastname: Choi
authors.affiliation: a College of Pharmacy, Yeungnam University , Gyeongsan , South Korea.
authors.forename: Chul Soon
authors.initials: CS
authors.lastname: Yong
authors.affiliation: a College of Pharmacy, Yeungnam University , Gyeongsan , South Korea.|b Pharmaceutical Research Centre, Hanmi Pharm. Co. , Hwaseong, Gyeonggi-Do , South Korea , and.
authors.forename: Jong Soo
authors.initials: JS
authors.lastname: Woo
authors.affiliation: a College of Pharmacy, Yeungnam University , Gyeongsan , South Korea.
authors.forename: Jong Oh
authors.initials: JO
authors.lastname: Kim
keywords: Bioavailability; irritable bowel syndrome; mosapride; probiotics; solubility