US 12,239,740 B2
Solid formulation
Wei Tian, Abingdon (GB); and Richard Zajicek, Abingdon (GB)
Assigned to Avaxzipen Limited, Abingdon (GB)
Filed by Avaxzipen Limited, Abingdon (GB)
Filed on Sep. 10, 2021, as Appl. No. 17/471,330.
Application 17/471,330 is a continuation of application No. 15/769,514, granted, now 11,135,170, previously published as PCT/GB2016/053276, filed on Oct. 20, 2016.
Claims priority of application No. 1518594 (GB), filed on Oct. 20, 2015.
Prior Publication US 2021/0401755 A1, Dec. 30, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/20 (2006.01); A61K 9/00 (2006.01); A61K 38/26 (2006.01); A61K 38/29 (2006.01); A61K 38/31 (2006.01)
CPC A61K 9/2054 (2013.01) [A61K 9/0021 (2013.01); A61K 9/0024 (2013.01); A61K 9/2009 (2013.01); A61K 9/2013 (2013.01); A61K 9/2018 (2013.01); A61K 9/205 (2013.01); A61K 9/2095 (2013.01); A61K 38/26 (2013.01); A61K 38/29 (2013.01); A61K 38/31 (2013.01)] 21 Claims
 
1. A solid dosage form comprising:
a freeze dried matrix including a first excipient and 0.01 to 50% (w/w) of a therapeutic peptide; and
a bulk component comprising the freeze dried matrix, one or more additional excipients and at least 5% (w/w) of carboxymethyl cellulose (CMC), based on the total weight of the solid dosage form,
wherein the dosage form has a maximum width of 0.5 mm to 2 mm,
wherein the dosage form has a pointed end configured to facilitate skin penetration,
wherein the pointed end is in the form of a cone or in the form of a beveled tip that is formed from two or more intersecting surfaces meeting at a common point,
wherein the first excipient is a polyol, sugar, surfactant, amino acid, EDTA and/or stabilising agent,
wherein the one or more additional excipients is at least one of a polyol, sugar, surfactant, amino acid, EDTA and/or stabilising agent, and
wherein the solid dosage form is injectable and has a moisture content of 5% (w/w) or less.