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Article | IMSEAR | ID: sea-206317

ABSTRACT

Mebeverine HCl is a BCS class-I drug and thus it possesses high solubility in aqueous media across the biological pH range. The marketed reference product is a multi-unit particulate system (MUPS) containing prolonged release pellets filled in hard gelatin capsule. In conventional manufacturing process, a huge quantity of solvents (aqueous and/or organic) is used to manufacture such dosage form. Additionally, it demands more processing time and efforts. Therefore, a prolonged release capsules dosage form of Mebeverine HCl was formulated using thermoplastic (melt) granulation technique without usage of any solvent. Prolonged release minitablets sized 2 mm in diameter were developed as per quality by design principles. A 23 full-factorial design of experiment was applied to optimize levels of drug release controlling ingredients which includes a hydrophobic meltable binder (hydrogenated castor oil) cum matrixing agent, a hydrophilic meltable binder (polyethylene glycol) which may act as pore former also, and a release controlling polymer (ethyl cellulose). The optimized formulation was found stable. Dissolution profiles of the optimized formulation were found similar to the marketed reference product in different media across the physiological pH range. In conclusion, the explored solvent less process was capable to manufacture the MUPS dosage form of Mebeverine HCl prolonged-release capsules, which is stable and pharmaceutically equivalent with the reference product. The developed process is more beneficial to small and medium scale industry, as it does not require any special and costly equipment, significantly decreases manufacturing cost and increases productivity compared to conventional process, which is mentioned in literature.

2.
RBM rev. bras. med ; 71(1-2)jan.-fev. 2014.
Article in Portuguese | LILACS-Express | LILACS | ID: lil-718720

ABSTRACT

A síndrome do intestino irritável (SII) é um distúrbio funcional do trato digestivo altamente prevalente, que causa significativo prejuízo da qualidade de vida e impacto econômico e no sistema de saúde. A fisiopatologia da SII é complexa e envolve alterações da motilidade intestinal, bem como aumento da sensibilidade visceral. Pela inexistência de um tratamento etiológico da SII, a abordagem terapêutica usual visa promover o alívio dos sintomas e a melhora da qualidade de vida. Juntamente com a dieta rica em fibras os antiespasmódicos são as medicações mais utilizadas no tratamento da SII. Assim, discutimos a eficácia e a segurança das medicações antiespasmódicas no tratamento da SII.

3.
Article in English | WPRIM | ID: wpr-76463

ABSTRACT

BACKGROUND/AIMS: Antispasmodics including otilonium bromide (OB) are recommended to treat irritable bowel syndrome (IBS). However, reports about OB experience in Asia is sparse. The purpose of present study was to provide the efficacy of OB in treating Asian IBS patients. METHODS: Overall, 117 IBS patients meeting Rome II criteria were enrolled in an 8-week, double-blind, active-controlled and single center trial. Randomized participants received either OB 40 mg or mebeverine 100 mg 3 doses daily. The primary endpoints were to evaluate the net changes of abdominal pain/discomfort frequency score (APDFS) and safety profile, while the secondary endpoints were to assess the changes in abdominal pain/discomfort intensity, flatulence, abdominal bloating, satisfied stool frequency etc. RESULTS: Finally, 49 OB and 52 mebeverine subjects were eligible for efficacy analysis. Compared to baselines in per protocol populations, the reduced APDFSs in OB and mebeverine were 0.55 +/- 1.20 (P = 0.011) and 0.37 +/- 1.11 (P = 0.042), respectively, to show similarly reduced scores. The most reported side effects included dry mouth, nausea and dizziness. Besides, the improved APDFSs at 4th week visit, final alleviations in abdominal pain intensity, flatulence, abdominal bloating and satisfied stool frequency with global assessments filled by both patients and investigators were significantly achieved by both treatments, and OB was not inferior to mebeverine in treating these parameters. CONCLUSIONS: In Orientals, OB is as effective as mebeverine for alleviating IBS symptoms in terms of abdominal pain, flatulence, abdominal bloating etc. However, obvious side effects are also observed. A large-scaled trial and post-marketing surveillance are recommended to confirm its efficacy and safety.


Subject(s)
Abdominal Pain , Asia , Asian Continental Ancestry Group , Dizziness , Flatulence , Humans , Irritable Bowel Syndrome , Mouth , Nausea , Parasympatholytics , Phenethylamines , Quaternary Ammonium Compounds , Research Personnel , Rome
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