Development Pharmaceutics of Doxepin Hydrochloride Orally Disintegrating Tablets for Dosing Flexibility to Physicians and Patient Compliance
An attempt was made to formulate, evaluate and commercialize Doxepin Hydrochloride orally disintegrating tablets 3 mg, 6 mg, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg. A direct blending and compression process by scale-up and scale-down approach / dose-proportional approach was followed to make the...
Gespeichert in:
Veröffentlicht in: | Journal of drug delivery and therapeutics 2024-12, Vol.14 (12), p.45-59 |
---|---|
Hauptverfasser: | , , , , , , , , , , , , , , |
Format: | Artikel |
Sprache: | eng |
Online-Zugang: | Volltext |
Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
Zusammenfassung: | An attempt was made to formulate, evaluate and commercialize Doxepin Hydrochloride orally disintegrating tablets 3 mg, 6 mg, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg. A direct blending and compression process by scale-up and scale-down approach / dose-proportional approach was followed to make the product. The excipients include 55% of Pearlitol Flash (Co-processed excipient of 80% D-Mannitol & 20% Maize Starch), 18% of Ludipress (Co-processed excipient of 93% Lactose Monohydrate, 3.5% Povidone K30 & 3.5% Polyplasdone XL), 0.2% of Peppermint Flavor 501500 TP0504, 0.4% of Sucralose and 1.4% of Magnesium Stearate. The composition and process was optimized as per IIG1 and SUPAC IR guidance document2. The final product exhibited rapid disintegration time complying with CDER’s guidance on orally disintegrating tablets3. The organoleptics of the final product was found acceptably flavored, exhibited smooth mouth feel and tasted pleasantly. Doxepin Hydrochloride is a BCS Class I drug (High Soluble and High Permeable) and accordingly the formulated ODT exhibited rapid disintegration and dissolution profile and hence qualifies for Bio-waiver4,5 The manufactured product was packed in both multi-dose bottle pack and special child lock enabled push-through provisioned unit dose amber colored PVC – ACLAR blister pack. The packed product was found to be stable for 6 months in ICH recommended accelerated stability storage condition at 40°C / 75%RH, hence qualifies for 2 years shelf life period at room temperature condition. The designed product was successfully commercialized under brand name InnAR-PZTM and found to be a cost-effective and differentiated alternative to tablet, capsule & oral liquid concentrate available in the market. Keywords: Doxepin, co-processed excipients, direct blending, compression, orally disintegrating tablet |
---|---|
ISSN: | 2250-1177 2250-1177 |
DOI: | 10.22270/jddt.v14i12.6909 |