Development and evaluation of a composite dosage form ...
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Development and evaluation of a composite dosage form containing desmopressin acetate for buccal administration
Dina Kottke, Bjoern B. Burckhardt, Tanja C. Knaab, J?rg Breitkreutz, Bj?rn Fischer
PII: DOI: Reference:
S2590-1567(21)00011-6 IJPX 100082
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Received date: Accepted date:
20 May 2021 24 May 2021
Please cite this article as: D. Kottke, B.B. Burckhardt, T.C. Knaab, et al., Development and evaluation of a composite dosage form containing desmopressin acetate for buccal administration, (2021),
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? 2021 The Author(s). Published by Elsevier B.V.
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Journal Pre-proof Development and Evaluation of a Composite Dosage Form Containing Desmopressin Acetate for Buccal Administration
Dina Kottke1, Bjoern B. Burckhardt2, Tanja C. Knaab1, J?rg Breitkreutz1, Bj?rn Fischer1,* bjoern.fischer@hhu.de
1Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universit?tsstr. 1, 40225 D?sseldorf, Germany 2Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University, Universit?tsstr. 1, 40225 D?sseldorf, Germany
*Corresponding author.
Abstract Desmopressin acetate (DDAVP) is an oligopeptide indicated for the treatment of primary nocturnal enuresis, for example. The poor oral bioavailability of DDAVP accelerated a shift to alternative routes of administration like nasal and oromucosal, whereby nasal administration results in high fluctuations increasing the risk of undesirable side effects. Aim of the study was to use a new composite dosage form (solid matrix attached to a bilayer mucoadhesive film) to make DDAVP available via oromucosal route, reducing the risk of undesirable side effects through precise dosing. DDAVP was incorporated into a solid matrix in the form of a minitablet, and both direct tableting (AV>30) and granulation followed by tableting (AV=17.86) were compared. Minitablets with content uniformity could only be obtained by granulation and loss supplementation (AV=11.27) with immediate drug release (>80% after 7?8 min) and rapid disintegration ( ................
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