Pharmaceutical suspensions containing drug particles, devices for their administration, and methods of their use
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-031/195
A61K-031/198
A61J-007/00
A61K-009/14
A61K-009/06
A61K-047/02
A61K-009/00
A61K-009/10
A61K-047/12
A61K-047/34
A61K-047/18
출원번호
US-0448208
(2017-03-02)
등록번호
US-9901561
(2018-02-27)
발명자
/ 주소
Heller, Adam
Heller, Ephraim
Westerberg, Karl Göran
Spiridigliozzi, John
출원인 / 주소
SynAgile Corporation
대리인 / 주소
Clark & Elbing LLP
인용정보
피인용 횟수 :
0인용 특허 :
62
초록
The invention features a pharmaceutical suspension containing drug particles, a drug delivery device anchored in the mouth for continuously administering the pharmaceutical suspension, and methods of their use.
대표청구항▼
1. A pharmaceutical composition comprising a suspension comprising (i) an oil, and (ii) from about 35% to 70% (w/w) solid drug particles comprising levodopa and/or carbidopa, wherein the pharmaceutical composition is physically stable and wherein said pharmaceutical composition is a non-pourable, pl
1. A pharmaceutical composition comprising a suspension comprising (i) an oil, and (ii) from about 35% to 70% (w/w) solid drug particles comprising levodopa and/or carbidopa, wherein the pharmaceutical composition is physically stable and wherein said pharmaceutical composition is a non-pourable, plastically deformable paste. 2. The pharmaceutical composition of claim 1, wherein after centrifugation for 1 hour at an acceleration of about 5,000 G at 25±3° C. the concentrations of drug in the layer containing the top 20 volume % and the layer containing the bottom 20 volume % of the composition differ by less than 4%. 3. The pharmaceutical composition of claim 2, wherein said suspension has a dynamic viscosity of at least 10,000 cP at 37° C. 4. The pharmaceutical composition of claim 1, wherein said suspension comprises less than or equal to about 30% (w/w) of said oil. 5. The pharmaceutical composition of claim 4, wherein said suspension comprises greater than or equal to about 19% (w/w) of said oil. 6. The pharmaceutical composition of claim 3, wherein said suspension comprises water and a surfactant. 7. The pharmaceutical composition of claim 1, wherein said solid drug particles comprise carbidopa, and wherein said pharmaceutical composition comprises less than 4 μg of hydrazine per mg of carbidopa after 12 month storage at 5±3° C., or less than 1 μg of hydrazine per mg of carbidopa after 3 month storage at 5±3° C. 8. The pharmaceutical composition of claim 1, said pharmaceutical composition comprising a suspension comprising (i) from about 35% to 70% (w/w) solid drug particles comprising levodopa and/or carbidopa, (ii) from 19% to 30% (w/w) of one or more water-immiscible compounds comprising an oil, (iii) from 2% to 16% (w/w) water, and (iv) from 1% to 8% (w/w) surfactant, wherein the pharmaceutical composition is suitable for continuous or frequent intermittent intra-oral delivery. 9. The pharmaceutical composition of claim 8, wherein said suspension has a dynamic viscosity of at least 10,000 cP at 37° C. 10. The pharmaceutical composition of claim 9, wherein said suspension has a dynamic viscosity of at least 100,000 cP at 37° C. 11. The pharmaceutical composition of claim 9, wherein after centrifugation for 1 hour at an acceleration of about 5,000 G at 25±3° C. the concentrations of drug in the layer containing the top 20 volume % and the layer containing the bottom 20 volume % of the composition differ by less than 4%. 12. The pharmaceutical composition of claim 9, wherein the shelf life of said pharmaceutical composition is 6 months or longer at 5±3° C. and said pharmaceutical composition does not substantially cream or sediment when stored for 6 months at 5±3° C. 13. The pharmaceutical composition of claim 9, wherein said suspension is a non-pourable, plastically deformable paste, and retains its shape at ambient temperature following extrusion through an orifice. 14. The pharmaceutical composition of claim 9, wherein said pharmaceutical composition comprises an emulsion. 15. The pharmaceutical composition of claim 9, wherein the suspension comprises greater than 50% (w/w) solid drug particles. 16. The pharmaceutical composition of claim 9, wherein the D50 of the solid drug particles is less than or equal to 25 μm when measured by light scattering with the particles dispersed in a non-solvent. 17. The pharmaceutical composition of claim 16, wherein the D50 of the solid drug particles is greater than or equal to 1 μm when measured by light scattering with the particles dispersed in a non-solvent. 18. The pharmaceutical composition of claim 9, wherein said suspension comprises less than or equal to about 12% (w/w) water. 19. The pharmaceutical composition of claim 18, wherein said suspension comprises 8±2% (w/w) water. 20. The pharmaceutical composition of claim 9, wherein said oil comprises a saturated fatty acid triglyceride, an unsaturated fatty acid triglyceride, a mixed saturated and unsaturated fatty acid triglyceride, a medium-chain fatty acid triglyceride, canola oil, coconut oil, palm oil, olive oil, soybean oil, sesame oil, corn oil, or mineral oil. 21. The pharmaceutical composition of claim 20, wherein said oil comprises a medium-chain fatty acid triglyceride. 22. The pharmaceutical composition of claim 9, wherein said pharmaceutical composition comprises a non-ionic surfactant. 23. The pharmaceutical composition of claim 22, wherein said non-ionic surfactant comprises a polyglycolized glyceride, an alkyl saccharide, an ester saccharide, or a polysorbate surfactant. 24. The pharmaceutical composition of claim 22, wherein said non-ionic surfactant comprises a poloxamer. 25. The pharmaceutical composition of claim 22, wherein said suspension comprises about 5±2% (w/w) of said surfactant. 26. The pharmaceutical composition of claim 9, wherein the pH of the composition measured by inserting a glass walled pH electrode into the formulation is less than pH 5 and remains less than pH 5 after 3 months storage at 25° C. 27. A pharmaceutical composition comprising a suspension comprising (i) from about 35% to 70% (w/w) solid drug particles comprising levodopa and/or carbidopa, (ii) from 19% to 30% (w/w) of one or more water-immiscible compounds comprising an oil, (iii) from 2% to 16% (w/w) water, (iv) from 1% to 8% (w/w) surfactant, and (v) benzoic acid or a benzoate salt wherein the pharmaceutical composition is physically stable, wherein the pharmaceutical composition is suitable for continuous or frequent intermittent intra-oral delivery, and wherein said suspension has a dynamic viscosity of at least 10,000 cP at 37° C. 28. A pharmaceutical composition comprising a suspension comprising (i) from about 35% to 70% (w/w) solid drug particles comprising levodopa and/or carbidopa, (ii) from 19% to 30% (w/w) of one or more water-immiscible compounds comprising an oil, (iii) from 2% to 16% (w/w) water, (iv) from 1% to 8% (w/w) surfactant, and (v) EDTA or its salt or salts, wherein the combined concentrations of EDTA and its salt or salts is between 0.05 weight % and 0.25 weight %, wherein the pharmaceutical composition is physically stable, wherein the pharmaceutical composition is suitable for continuous or frequent intermittent intra-oral delivery, and wherein said suspension has a dynamic viscosity of at least 10,000 cP at 37° C. 29. The pharmaceutical composition of claim 1, wherein said pharmaceutical composition comprises: (i) from about 50% to about 75% (w/w) of said solid drug particles; (ii) 8±2% (w/w) water, (iii) 24±2% (w/w) of said oil, wherein said oil is a medium-chain fatty acid triglyceride; and (iv) 5±2% (w/w) of a surfactant that is a poloxamer.
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