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Silodosin oral films: Development, physico-mechanical properties and in vitro dissolution studies in simulated saliva
Luleå University of Technology, Department of Health Sciences, Medical Science. College of Pharmacy, University of Mosul, Mosul, Iraq.ORCID iD: 0000-0002-2273-457x
Research Centre for Topical Drug Delivery and Toxicology, Department of Clinical and Pharmaceutical Sciences, School of Life and Medical Sciences, University of Hertfordshire, UK.
Luleå University of Technology, Department of Health Sciences, Medical Science.ORCID iD: 0000-0002-0654-5410
2019 (English)In: Journal of Drug Delivery Science and Technology, ISSN 1773-2247, Vol. 53, article id 101122Article in journal (Refereed) Published
Abstract [en]

Sublingual film dosage forms for drugs used for fast symptomatic treatment have promise because they allow a rapid onset of action. The aim of this study was to prepare films of silodosin intended for sublingual administration for the symptomatic treatment of benign prostatic hyperplasia in men. Hydroxypropyl methylcellulose (HPMC) or hydroxypropyl methylcellulose acetate succinate (HPMC-AS) were used as film-forming polymers. The effects of the polymers and the surfactant tocopherol polyethylene glycol succinate (TPGS) on the physico-mechanical properties and dissolution behavior of the films in simulated saliva were investigated. The eight silodosin oral films developed (F1–F8) contained 8 mg silodosin per 6 cm2 film and HPMC or HPMC-AS in drug:polymer ratios of 1:5 or 1:3, while four also contained TPGS (0.5% w/w). The films were characterized using DSC, TGA, SEM, and PXRD and the mechanical properties were investigated by measuring tensile strength, elongation at break and Young's modulus. The mechanical properties of the films were dependent on the ratio of polymer used. The in vitro dissolution and drug release studies indicated that HPMC-AS films disintegrated more quickly than HPMC films. Silodosin was shown to be dispersed within the polymers. Despite silodosin being submicronized in the HPMC films, the dissolution and drug release rate (time for 80% release) from HPMC films was significantly faster than from HPMC-AS films. TPGS increased the drug release rate to a greater extent with HPMC than with HPMC-AS. The degree of saturation of formulation F4 was >1, which shows potential for improving oral absorption of silodosin.

Place, publisher, year, edition, pages
Elsevier, 2019. Vol. 53, article id 101122
Keywords [en]
Silodosin, Sublingual oral films, HPMC, HPMC-AS, TPGS, Simulated saliva
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Other Health Sciences
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Health Science
Identifiers
URN: urn:nbn:se:ltu:diva-75248DOI: 10.1016/j.jddst.2019.06.019OAI: oai:DiVA.org:ltu-75248DiVA, id: diva2:1335878
Note

Validerad;2019;Nivå 2;2019-07-08 (johcin)

Available from: 2019-07-08 Created: 2019-07-08 Last updated: 2019-07-08Bibliographically approved

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AlHayali, AmaniVelaga, Sitaram

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