Recipient-dosage delivery system

• US 5,965,164 A
• Filed: 04/29/1996
• Issued: 10/12/1999
• Est. Priority Date: 10/28/1994
• Status: Expired due to Fees

• Current Assignee: Fuisz Technologies Limited (Bausch Health Cos., Inc.)
• Original Assignee: Fuisz Technologies Limited (Bausch Health Cos., Inc.)
• Inventors: Yang, Robert K., Fuisz, Richard C., Myers, Garry L., Herman, Mark R., Cavanagh, Whitney S.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Benston, Jr., William E.
• Application Number:
  US08/642,027
• Time in Patent Office: 1,261 Days
• Field of Search: 424/489, 424/447, 156/184, 604/307
• US Class Current: 424/489
• CPC Class Codes: A61J 1/00 Containers specially adapted for medical or pharmaceutical purposes capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00
• CPC Class Codes: A61J 7/0015 Devices specially adapted for taking medicines
• CPC Class Codes: A61J 7/0023 Spoons
• CPC Class Codes: A61J 7/0046 Cups, bottles or bags
• CPC Class Codes: A61K 9/1688 resulting in pure drug agglomerate optionally containing up to 5% of excipient
• CPC Class Codes: A61K 9/1694 resulting in granules or microspheres of the matrix type containing more than 5% of excipient
• CPC Class Codes: A61K 9/2081 with microcapsules or coated microparticles according to A61K9/50
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00
• CPC Class Codes: A61K 9/5026 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: B01J 2/00 Processes or devices for granulating materials , e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
• CPC Class Codes: B01J 2/02 by dividing the liquid material into drops, e.g. by spraying, and solidifying the drops
• CPC Class Codes: G06V 20/66 Trinkets, e.g. shirt buttons or jewellery items recognising microscopic objects G06V20/69

Abstract

A recipient-dosage delivery system including shearlite particles of a bio-affecting agent for delivery to a recipient. The particles are provided in a metered dose and are packaged in a bi-functional vessel. The particles are produced under liquiflash conditions and exhibit sufficient flowability so as to allow administration of the metered dose to the recipient under the force of gravity.

Claims

1. A recipient-dosage delivery system, for oral use comprising:

i) shearlite particles of a bio-affecting agent for delivery to the oral cavity of a recipient, said particles provided in a metered dose and sufficiently flowable to be administered under the force of gravity;

ii) a bi-functional vessel for sterile storage and transportation of said particles and for subsequent delivery of said particles to said recipient.

2. The system according to claim 1, wherein said vessel is shaped to facilitate delivery of said particles directly from said vessel to a receiving cavity of said recipient.

3. The system according to claim 2, wherein said vessel is sealed closed with a removable closure, and whereupon removal of said closure allows access to said vessel-confined particles for delivery thereof.

4. The system according to claim 1, wherein said vessel is detachably secured to at least one second vessel thus providing a multi-vessel transportable package of said recipient-dosage contact delivery systems.

5. The system according to claim 4, wherein said first and second vessels are sealed closed with removable closures, and wherein said vessels are arranged to allow simultaneous removable of said closures for simultaneous delivery of said metered dosages.

6. The system according to claim 1, wherein said shearlite particles are capable of undergoing restricted flow under the force of gravity;

and

wherein said vessel includes a restricted flow passage which is traversed by said vessel-confined particles during delivery thereof.

7. The system according to claim 1, wherein said vessel comprises a particle-storing bowl affixed to a finger-engaging handle, said bowl defining a surrounding rim.

8. The system according to claim 7, wherein said bowl is sealingly closed with a peel-away backing during storage and transportation of said vessel, said peel-away backing being secured around said rim of said bowl.

9. The system according to claim 8, further comprising a second vessel having a second particle-storing bowl and a second finger engaging handle, and wherein said second handle is attached to the first handle so that said bowls are positioned opposite one another.

10. The system according to claim 1, wherein said vessel comprises a flask-shaped particle-storing body having an elongated neck fluidly connected thereto which allows flow of said particles from said body to said recipient.

11. The system according to claim 10, wherein said neck is formed with a breakaway lid, and wherein said lid is secured to a finger-engaging tab which upon application of pressure thereto allows said recipient to readily remove said lid from said neck.

12. The system according to claim 11, wherein said vessel is detachably secured to a second similarly configured vessel such that said elongated necks are arranged parallel to one another.

13. The system according to claim 11, wherein said vessel is detachably secured to a second similarly configured vessel such that said elongated necks are arranged along a common axis, and wherein each said lid is secured to a common centrally-disposed finger engaging tab.

14. The system according to claim 1, wherein said vessel comprises an open sided particle-storing container defined by a circumferentially-extending rim, said container being sealingly closed with a peel-away cover during storage and transportation of said vessel, said peel-away cover being secured around said rim of said container.

15. The system according to claim 1, wherein said vessel comprises an elongate tubular particle-storing body having a removable cap releasably secured to one end thereof.

16. The system according to claim 1, wherein said shearlite particles are produced by the process of

a) subjecting a solid organic-based feedstock capable of being transformed to a liquiform in the substantial absence of dissolving medium to liquiflash conditions to provide substantially unimpeded internal flow of said feedstock, and

b) imparting shear force on said flowing feedstock resulting from step "a" in an amount sufficient to separate particles discretized by natural mass separation of said flowing feedstock in the presence of said shear force impinging thereon while in said unimpeded-flow condition.

17. The system according to claim 16, wherein said bio-affecting agent is selected from the group consisting of antitussives, antihistamines, decongestants, alkaloids, mineral supplements, laxatives, vitamins, antacids, ion exchange resins, anti-cholesterolemics, anti-lipid agents, antiarrhythmics, antipyretics, analgesics, appetite suppressants, expectorants, anti-anxiety agents, anti-ulcer agents, anti-inflammatory substances, coronary dilators, cerebral dilators, peripheral vasodilators, anti-infectives, psycho-tropics, antimanics, stimulants, gastrointestinal agents, sedatives, antidiarrheal preparations, anti-anginal drugs, vasodialators, antihypertensive drugs, vasoconstrictors, migraine treatments, antibiotics, tranquilizers, anti-psychotics, antitumor drugs, anticoagulants, antithromobotic drugs, hypnotics, anti-emetics, anti-nauseants, anti-convulsants, neuromuscular drugs, hyper- and hypoglycemic agents, thyroid and antithyroid preparations, diuretics, antispasmodics, uterine relaxants, mineral and nutritional additives, antiobesity drugs, anabolic drugs, erythropoietic drugs, antiasthmatics, cough suppressants, mucolytics, H₂ -antagonists, anti-uricemic drugs and mixtures thereof.

18. The system according to claim 1, further comprising a flavor enhancer delivered together with said shearlite particles.

19. The system according to claim 18, wherein said flavor enhancer is coated on said shearlite particles.

29. The system of claim 1 wherein said flowable shearlite particles are spherical.

30. The system of claim 1 wherein the bio-affecting agent is an analgesic.

31. The system of claim 30 wherein the analgesic is aspirin.

38. The system of claim 30 wherein the vessel is sealed closed with a removable closure.

39. The system of claim 31 wherein the vessel is sealed closed with a removable closure.

40. The system of claim 1 wherein the vessel is designed to eliminate adherence to boundaries, caking and dusting of multiparticulates therein.

41. The system of claim 1 wherein the particles in the vessel will flow away from a boundary of the vessel without any significant adherence of the particles to the boundary.

42. The system of claim 41 wherein the boundary is a wall.

20. A method for oral delivering a metered dose of a bio-affecting agent directly to a recipient, comprising:

i) sealingly packaging a metered dose of shearlite particles of a bio-affecting agent in a bifunctional storage and delivery vessel;

ii) accessing and thereafter orally administering said packaged particles at an angle of repose effective to induce flow of said particles from said container to the oral cavity of said recipient.

21. The method according to claim 20, wherein said angle of repose is less than about 45°

.

22. The method according to claim 20, wherein said shearlite particles are produced by the process of

a) subjecting a solid, organic feedstock, capable of being transformed to a liquiform in the substantial absence of dissolving medium, to liquiflash conditions to provide substantially unimpeded internal flow of said feedstock, and

b) imparting shear force on said flowing feedstock resulting from step "a" in an amount sufficient to separate particles discretized by natural mass separation of said flowing feedstock in the presence of said shear force impinging thereon while in said unimpeded-flow condition.

23. The method according to claim 22, wherein said bioaffecting agent is selected from the group consisting of antitussives, antihistamines, decongestants, alkaloids, mineral supplements, laxatives, vitamins, antacids, ion exchange resins, anti-cholesterolemics, anti-lipid agents, antiarrhythmics, antipyretics, analgesics, appetite suppressants, expectorants, anti-anxiety agents, anti-ulcer agents, anti-inflammatory substances, coronary dilators, cerebral dilators, peripheral vasodilators, anti-infectives, psycho-tropics, antimanics, stimulants, gastrointestinal agents, sedatives, antidiarrheal preparations, anti-anginal drugs, vasodialators, anti-hypertensive drugs, vasoconstrictors, migraine treatments, antibiotics, tranquilizers, anti-psychotics, antitumor drugs, anticoagulants, antithromobotic drugs, hypnotics, anti-emetics, anti-nauseants, anti-convulsants, neuromuscular drugs, hyper- and hypoglycemic agents, thyroid and antithyroid preparations, diuretics, antispasmodics, uterine relaxants, mineral and nutritional additives, antiobesity drugs, anabolic drugs, erythropoietic drugs, antiasthmatics, cough suppressants, mucolytics, H₂ -antagonists, anti-uricemic drugs and mixtures thereof.

32. The method of claim 20 wherein said flowable shearlite particles are spherical.

33. The method of claim 20 wherein the bio-affecting agent is an analgesic.

34. The system of claim 33 wherein the analgesic is aspirin.

24. A delivery system for oral use, comprising:

i) shearlite particles produced by a liquiflash process, said particles provided in a metered dose and sufficiently flowable to be administered orally under the force of gravity;

ii) a vessel for storage and subsequent delivery of said particles.

25. The system according to claim 24, wherein said shearlite particles are produced by liquiflash processing of sucrose, and wherein said shearlite particles carry a bio-affecting agent.

26. The system according to claim 24, wherein said shearlite particles are produced by liquiflash processing of an industrial chemical, and wherein said processed industrial chemical exhibits reduced dusting and enhanced flowability.

27. The system according to claim 24, wherein said shearlite particles include an active ingredient.

28. The system according to claim 24, further comprising at least a first and a second vessel, wherein said first vessel is detachably secured to at least said second vessel thus providing a multi-vessel transportable package of said recipient-dosage delivery systems;

and

wherein said at least first and second vessels are sealed closed with removable closures, and wherein said vessels are arranged to allow simultaneous removable of said closures for simultaneous delivery of said metered doses.

35. The system of claim 24 wherein said flowable shearlite particles are spherical.

36. The system of claim 24 wherein the bio-affecting agent is an analgesic.

37. The system of claim 36 wherein the analgesic is aspirin.