Multi-site drug delivery platform

• US 20050101936A1
• Filed: 11/06/2003
• Published: 05/12/2005
• Est. Priority Date: 11/06/2003
• Status: Active Grant

• Current Assignee: Paolo L. Manfredi
• Original Assignee: Pediamed Pharmaceuticals, Inc.
• Inventors: Gonzales, Gilbert R., Manfredi, Paolo L.
• Granted Patent: US 8,157,788 B2
• Time in Patent Office: Days
• US Class Current: 604/514
• CPC Class Codes: A61J 3/07 into the form of capsules or similar small containers for oral use
• CPC Class Codes: A61J 3/08 into the form of suppositories or sticks
• CPC Class Codes: A61J 7/003 Sticks, e.g. lollipops with drug release
• CPC Class Codes: A61J 7/0053 Syringes, pipettes or oral dispensers
• CPC Class Codes: A61K 9/0031 Rectum, anus
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/02 Suppositories; Bougies; Bases therefor; Ovulesapparatus for making A61J3/08; devices for introducing into the body A61M31/00
• CPC Class Codes: A61K 9/025 characterised by shape or structure, e.g. hollow layered, coated
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A pharmaceutical composition for administration to a patient body. The composition includes a physiologically-acceptable formulation including at least one active pharmaceutical ingredient, wherein said physiologically-acceptable formulation including said at least one active pharmaceutical ingredient is provided in a delivery form, said delivery form being administrable to a patient body through a plurality of administration routes, which include the oral and rectal routes.

Claims

1. A pharmaceutical composition for administration to a patient body, comprising:

a physiologically acceptable formulation including at least one active pharmaceutical ingredient;

wherein said physiologically-acceptable formulation including said at least one active pharmaceutical ingredient is provided in a delivery form, said delivery form being alternatively administrable to a patient body through an oral administration route and a rectal administration route.

2. The composition of claim 1, wherein said oral administration route is selected from the group consisting of an oral transmucosal route and an oral gastrointestinal route.

3. The composition of claim 1, wherein said rectal administration route further comprises a rectal transmucosal route.

4. The composition of claim 1, wherein said delivery form is selected from the group consisting of a solid delivery form and a non-solid delivery form.

5. The composition of claim 4, wherein said solid delivery form is selected from the group consisting of a suppository, a lozenge, a swallowable tablet, a chewable tablet, and a dissolvable tablet.

6. The composition of claim 5 wherein said physiologically acceptable formulation further includes at least one additive selected from the group consisting of flavoring agents, coloring agents, sweetening agents, preservatives, adhesive-promoting agents, and glidants.

7. The composition of claim 5, wherein said solid delivery form includes a proximal end, a distal end, and a central bore disposed in said distal end.

8. The composition of claim 7, further comprising a handle, said handle being adapted to be operatively connected to said delivery form.

9. The composition of claim 8, wherein said handle is threaded.

10. The composition of claim 5, wherein said active pharmaceutical ingredient is selected from the group consisting of analgesics, anti-allergy medications, anti-asthma medications, antibiotics, antiviral drugs, antifungal drugs, anticholinergics, anticonvulsants, antidepressants, antihistamines, antiemetics, antiseizure, antispasmodics, aminophylline, ascorbic acid, aspirin, acetaminophen, barbiturates, benzodiazepines, bisacodyl, butyrophenones, caffeine, chloral hydrate, chlorpromazine, clindamycin, clotrimazole, codeine, corticosteroids, dextromethorphan, diazepam, dinoprostone, diphenhydramine, ergotamine, estrogens, fentanyl, ferrous sulfate, guaifenesin, haloperidol, hormonal supplements, hydromorphone, indomethacin, kaolin, pectin, laxatives, lithium, loperamide, meclizine, meprobamate, methadone, metronidazole, miconazole, morphine, NSAIDS, opioids, orphenadrine, oxymorphone, pentobarbital, phenobarbital, phenothiazines, phenyloin, prochlorperazine, progestins, promethazine, ritalin, simethicone, spiramycin, sulfonamides, theophylline, trimethobenzamide, valproic acid, and vitamins.

11. The composition of claim 4, wherein said non-solid delivery form is selected from the group consisting of a gel, a liquid, a paste, and a foam.

12. The composition of claim 11, wherein said active pharmaceutical ingredient is selected from the group consisting of analgesics, anti-allergy medications, anti-asthma medications, antibiotics, antiviral drugs, antifungal drugs, anticholinergics, anticonvulsants, antidepressants, antihistamines, antiemetics, antiseizure, antispasmodics, aminophylline, ascorbic acid, aspirin, acetaminophen, barbiturates, benzodiazepines, bisacodyl, butyrophenones, caffeine, chloral hydrate, chlorpromazine, clindamycin, clotrimazole, codeine, corticosteroids, dextromethorphan, diazepam, dinoprostone, diphenhydramine, ergotamine, estrogens, fentanyl, ferrous sulfate, guaifenesin, haloperidol, hormonal supplements, hydromorphone, indomethacin, kaolin, pectin, laxatives, lithium, loperamide, meclizine, meprobamate, methadone, metronidazole, miconazole, morphine, NSAIDS, opioids, orphenadrine, oxymorphone, pentobarbital, phenobarbital, phenothiazines, phenyloin, prochlorperazine, progestins, promethazine, ritalin, simethicone, spiramycin, sulfonamides, theophylline, trimethobenzamide, valproic acid, and vitamins.

13. The composition of claim 11, further comprising an applicator adapted to facilitate administration of said physiologically acceptable formulation including said active pharmaceutical ingredient to both the oral and rectal cavity.

14. The composition of claim 11 further comprising the addition of ingredients to promote adhesiveness to the oral and rectal mucosa.

15. The composition of claim 13, wherein said applicator includes a delivery component.

16. The composition of claim 15, wherein said delivery component is selected from the group consisting of a plunger, and a squeezable component.

17. The composition of claim 1, wherein said physiologically-acceptable formulation further includes a base component, and wherein said base component is selected from the group consisting of glycerinated gelatin, polyethylene glycol, and MBK fatty acid.

18. The composition of claim 1, further comprising at least one excipient ingredient.

19. The composition of claim 18, wherein said at least one excipient ingredient is selected from the group consisting of mannitol, dextrose, lactose, sucrose, and calcium carbonate.

20. The composition of claim 5, further comprising a score mark disposed in a surface of said delivery form.

21. The composition of claim 20, wherein said score mark is disposed in said surface at a location reflective of the rate of absorption of said at least one active pharmaceutical ingredient in the oral cavity, gut, or rectum of said patient body.

22. The composition of claim 4 where a solid or nonsolid composition is enclosed in a capsule that can be swallowed or inserted rectally.

23. The composition of claim 1, wherein said delivery form is further alternatively administrable to a patient body through a nasal administration route.

24. A method of administering a composition to a patient, the method comprising:

providing a composition for administration to a patient body, the composition comprising a physiologically acceptable formulation including at least one active pharmaceutical ingredient, wherein said formulation including said at least one active pharmaceutical ingredient is provided in a single unit delivery form, said single unit delivery form being administrable to a patient body through a plurality of administration routes;

selecting an oral or a rectal administration route; and

delivering said composition in said delivery form to said patient via either said oral administration route or said rectal administration route.

25. The method of claim 24, wherein said oral administration route is selected from the group consisting of an oral transmucosal route and an oral gastrointestinal route.

26. The method of claim 25, wherein said rectal administration route further comprises a rectal transmucosal route.

27. The method of claim 26, wherein said delivery form is selected from the group consisting of a solid and a non-solid.

28. The method of claim 27, wherein said solid delivery form is selected from the group consisting of a suppository, a lozenge, a swallowable tablet, a chewable tablet, and a dissolvable tablet.

29. The method of claim 28, wherein said solid delivery form is a suppository, and said composition is administered via said rectal administration route.

30. The method of claim 28, wherein said solid delivery form is a suppository and further comprising adapting said delivery form to be administered via said oral administration route.

31. The method of claim 30, wherein said solid delivery form includes a proximal end, a distal end, and a central bore disposed in said distal end.

32. The method of claim 31, further comprising a handle, wherein the method further comprises operatively connecting said handle to said delivery form.

33. The method of claim 32, wherein said handle is threaded and said bore is complementarily threaded and operatively connecting said handle to said delivery form includes bringing said handle into receiving relationship with said bore and rotating said handle relative to said delivery form.

34. The method of claim 27, wherein said non-solid delivery form is selected from the group consisting of a gel, a liquid, a paste, and a foam.

35. The method of claim 34, further comprising an applicator, and further comprising operating said applicator to administer said at least one active pharmaceutical ingredient to said patient body.

36. The method of claim 28, wherein said solid delivery form further comprises a score mark disposed in a surface of said delivery form, the location of said score mark being reflective of the total dose delivered and the rate of absorption of said at least one pharmaceutical ingredient in said patient body.

37. The method of claim 36, further comprising administering said solid delivery form intact to one of said oral or said rectal administration routes.

38. The method of claim 37, further comprising breaking said solid delivery form along said score mark into first and second portions and administering either said first or said second portion to said patient body via the other of said oral and said rectal administration routes.