US 12,186,426 B2
Solid dosage form
Chin Beng Stephen Lim, Willeton (AU); Vivian Bruce Sunderland, Claremont (AU); and Yip Hang Eddy Lee, Singapore (SG)
Assigned to IX Biopharma Ltd., Singapore (SG)
Filed by IX BIOPHARMA LTD, Singapore (SG)
Filed on Aug. 11, 2020, as Appl. No. 16/990,739.
Application 16/990,739 is a division of application No. 16/020,880, filed on Jun. 27, 2018, granted, now 10,857,097.
Application 16/020,880 is a continuation of application No. 14/052,331, filed on Oct. 11, 2013, abandoned.
Application 14/052,331 is a continuation in part of application No. 13/504,309, granted, now 10,744,086, previously published as PCT/SG2010/000409, filed on Oct. 26, 2010.
Claims priority of application No. 200907221-6 (SG), filed on Oct. 30, 2009; application No. 2012238330 (AU), filed on Oct. 11, 2012; application No. 2013200684 (AU), filed on Feb. 8, 2013; and application No. 2013200682 (AU), filed on Aug. 8, 2013.
Prior Publication US 2022/0347095 A1, Nov. 3, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/20 (2006.01); A61K 9/00 (2006.01); A61K 9/19 (2006.01); A61K 31/00 (2006.01); A61K 31/135 (2006.01); A61K 31/137 (2006.01); A61K 31/439 (2006.01); A61K 31/4468 (2006.01); A61K 31/519 (2006.01); A61K 31/5517 (2006.01); A61K 31/724 (2006.01); A61K 47/26 (2006.01)
CPC A61K 9/0056 (2013.01) [A61K 9/2018 (2013.01); A61K 9/2095 (2013.01); A61K 31/00 (2013.01); A61K 31/135 (2013.01); A61K 31/137 (2013.01); A61K 31/439 (2013.01); A61K 31/4468 (2013.01); A61K 31/519 (2013.01); A61K 31/5517 (2013.01)] 11 Claims
 
1. A fast disintegrating and dissolving solid freeze-dried wafer dosage form with a porous matrix for the release of a biologically active material in an oral cavity wherein said dosage form comprises:
a) biologically active material at a concentration of 0.02 to 95% by dry weight of the dosage form;
b) a matrix forming agent comprising amylopectin that is not in the form of starch or modified starch at a concentration from 2% to 17% by dry weight of the dosage form; and
c) a further matrix forming agent comprising a carbohydrate chosen from the list consisting of: mannitol, dextrose, lactose, galactose, trehalose and cyclodextrin at a concentration from 5% to 80% by dry weight of the dosage form
wherein said dosage form disintegrates in the oral cavity, and
wherein said biologically active material is absorbed by diffusion directly into the systemic circulation, and
wherein the biologically active material is selected from the group consisting of: anti-arrhythmic agents; anti-hypertensive agents; anti-migraine agents; anxiolytic, sedative, hypnotic and neuroleptic agents; gastro-intestinal agents; histamine H-receptor antagonists; nutritional agents; opioid analgesics; proteins, peptides and recombinant drugs; vasodilators; analgesics and anti-inflammatory agents, and
when analysed by powder x-ray diffraction (XRD), the wafer exhibits peaks located at 2-theta values of approximately 9.58 degrees, approximately 19.68 degrees, and approximately 20.05 degrees.