US 12,447,129 B2
Solid dosage form production
Mohamed Albed Alhnan, Preston (GB)
Assigned to University of Lancashire, Preston (GB)
Filed by University of Lancashire, Preston (GB)
Filed on Aug. 7, 2023, as Appl. No. 18/231,054.
Application 18/231,054 is a division of application No. 15/508,538, granted, now 11,771,655, previously published as PCT/GB2015/052595, filed on Sep. 8, 2015.
Claims priority of application No. 1415811 (GB), filed on Sep. 8, 2014; and application No. 1502041 (GB), filed on Feb. 6, 2015.
Prior Publication US 2024/0156739 A1, May 16, 2024
Int. Cl. A61K 9/20 (2006.01); A61K 9/00 (2006.01); A61K 47/10 (2017.01); A61K 47/32 (2006.01); A61K 47/38 (2006.01); B29C 64/118 (2017.01); B29C 64/209 (2017.01); B29C 64/245 (2017.01); B29C 64/314 (2017.01); B29C 64/393 (2017.01); B33Y 50/02 (2015.01); B33Y 70/00 (2020.01); B29K 105/00 (2006.01); B29L 31/00 (2006.01)
CPC A61K 9/2095 (2013.01) [A61K 9/0087 (2013.01); A61K 47/10 (2013.01); A61K 47/32 (2013.01); A61K 47/38 (2013.01); B29C 64/118 (2017.08); B29C 64/209 (2017.08); B29C 64/245 (2017.08); B29C 64/314 (2017.08); B29C 64/393 (2017.08); B33Y 50/02 (2014.12); B33Y 70/00 (2014.12); B29K 2105/0035 (2013.01); B29L 2031/753 (2013.01)] 16 Claims
OG exemplary drawing
 
1. A solid dosage form, which is an orally-administrable immediate release tablet comprising a pharmaceutical active ingredient, obtainable by a method of printing a solid dosage form comprising:
a) providing a solid dosage form printing apparatus comprising:
a fused filament fabrication (FFF) 3D printer;
a build platform upon which the solid dosage form is printable;
an active ingredient-containing printing filament, wherein the active ingredient-containing printing filament comprises an active ingredient-containing filament composition comprising: the pharmaceutical active ingredient and an active ingredient carrier, wherein the active ingredient-containing filament is solid at standard ambient temperature and pressure (SATP);
optionally one or more further printing filaments, each suitably independently comprising a further filament composition;
at least one heated extrusion nozzle through and from which the active ingredient-containing printing filament and optionally one or more further printing filaments can be extruded; and
a computer for controlling the FFF 3D printer and optionally also the build platform;
b) operating the FFF 3D printer to print the orally-administrable, immediate release solid dosage form upon the build platform via a process comprising:
i) printing the active ingredient-containing printing filament through the at least one heated extrusion nozzle; and
ii) optionally printing one or more further printing filaments; and
c) optionally performing one or more further processing steps;
wherein the active ingredient-containing printing filament is formed via hotmelt extrusion of a hotmelt mixture prepared by mixing together at least the pharmaceutical active ingredient and the active ingredient carrier; wherein the mixing together is performed at a mixing temperature (T1) that is between 7° and 150° C. and the hotmelt extrusion is performed at a hotmelt extrusion temperature (T2) that is 10 to 50° C. lower than the mixing temperature;
wherein the operating temperature (T3) of the at least one heated extrusion nozzle through which the active ingredient-containing printing filament passes is between 9° and 220° C.;
wherein the hotmelt extrusion temperature (T2) is between 30 and 90° C. lower than the operating temperature (T3) of the at least one heated extrusion nozzle through which the active ingredient-containing printing filament passes; and
the active ingredient carrier is a polymer having a glass transition temperature at least 50° C. lower than the melting point of the pharmaceutical active ingredient.