US 11,911,476 B2
Process for preparing a drug delivery composition
Philippe Pouletty, Paris (FR); and Frédérique Guillamot, Gerzat (FR)
Assigned to PK MED, Paris (FR)
Appl. No. 16/634,137
Filed by PK MED SAS, Paris (FR)
PCT Filed Jul. 25, 2018, PCT No. PCT/EP2018/070139
§ 371(c)(1), (2) Date Jan. 25, 2020,
PCT Pub. No. WO2019/020678, PCT Pub. Date Jan. 31, 2019.
Claims priority of application No. 17305993 (EP), filed on Jul. 25, 2017.
Prior Publication US 2020/0368357 A1, Nov. 26, 2020
Int. Cl. A61K 47/34 (2017.01); B29C 48/00 (2019.01); A61K 31/485 (2006.01); A61K 38/47 (2006.01); A61L 17/12 (2006.01); A61L 24/00 (2006.01); A61L 24/04 (2006.01); A61L 27/18 (2006.01); A61L 27/54 (2006.01); A61L 31/06 (2006.01); A61L 31/16 (2006.01); C07K 16/24 (2006.01); B29K 67/00 (2006.01); B29K 105/00 (2006.01)
CPC A61K 47/34 (2013.01) [A61K 31/485 (2013.01); A61K 38/47 (2013.01); A61L 17/12 (2013.01); A61L 24/0015 (2013.01); A61L 24/046 (2013.01); A61L 27/18 (2013.01); A61L 27/54 (2013.01); A61L 31/06 (2013.01); A61L 31/16 (2013.01); B29C 48/022 (2019.02); C07K 16/241 (2013.01); A61L 2300/216 (2013.01); A61L 2300/254 (2013.01); B29K 2067/043 (2013.01); B29K 2067/046 (2013.01); B29K 2105/0035 (2013.01); B29K 2105/0085 (2013.01)] 23 Claims
OG exemplary drawing
 
1. A process for preparing a drug delivery composition comprising at least a drug, comprising the steps of
a) preparing a masterbatch comprising a drug and a first polymer by
(i) heating the first polymer, wherein said first polymer has a melting temperature below 140° C.; and
(ii) introducing the drug during heating of the first polymer, with a drug content between 0.1% and 90%, based on the total weight of the masterbatch; and
b) introducing the masterbatch in a polymer-based matrix during production of the drug delivery composition,
wherein step a) is performed at a temperature at which the first polymer is in a partially or totally molten state, and step b) is performed at a temperature at which both the first polymer and at least a polymer of the polymer-based matrix are in a partially or totally molten state,
wherein the drug is selected from bone regenerative enzymes, hormones, cytokines, monoclonal antibodies and antigens;
and wherein the drug has a molecular mass above 14 kDa.