Compositions and kits for compounding pharmaceuticals

• US 6,708,822 B1
• Filed: 11/07/2000
• Issued: 03/23/2004
• Est. Priority Date: 11/30/1999
• Status: Expired due to Term

• Current Assignee: Cutispharma, Inc. (Azurity Pharmaceuticals, Inc.)
• Original Assignee: Cutispharma, Inc. (Azurity Pharmaceuticals, Inc.)
• Inventors: Muni, Indu A.
• Primary Examiner(s): CLARDY, S
• Application Number:
  US09/707,783
• Time in Patent Office: 1,232 Days
• Field of Search: 206/538, 206/539, 206/438, 206/568, 206/570, 206/828, 514/179
• US Class Current: 206/438
• 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: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/196 the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
• CPC Class Codes: A61K 31/46 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
• CPC Class Codes: A61K 31/5415 ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/568 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 47/06 Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: Y10S 206/828 Medicinal content

Abstract

The invention provides compositions and methods for the convenient compounding of pharmaceuticals. Single and multiple unit of use kits are provided which contain all the necessary components required for preparing a compounded pharmaceutical.

Claims

1. A kit for compounding pharmaceuticals comprising:

a first container comprising an active agent,

a second container comprising at least one inactive agent, and

instructions for use,

wherein the active agent and the at least one inactive agent each is pre-measured into a respective unit of use amount,

wherein the at least one inactive agent occupies a volume in the second container equal to or less than the volume of the second container minus the volume of the active agent, and

wherein a mixture of the active agent and the at least one inactive agent comprises a compounded pharmaceutical selected from the group consisting of testosterone and petrolatum, hydrocortisone and ultrasound gel and an anti-foaming agent, triamcinolone and coal tar, ketoprofen and PLO gel, progesterone and cream, progesterone and PLO gel, diclofenac and PLO gel, testosterone and cream, testosterone and ointment, promethazine and PLO gel, scopolamine and PLO gel, estrogen in lactose, estrogen and progesterone in lactose, magnesium hydroxide/aluminum hydroxide and diphenhydramine hydrochloride, magnesium hydroxide/aluminum hydroxide and diphenhydramine hydrochloride and nystatin, magnesium hydroxide/aluminum hydroxide and diphenhydramine hydrochloride and lidocaine-HCl, and lidocaine, adrenaline and tetracaine (LAT), and

wherein the anti-foaming agent is present in an amount of 0.01-10% (w/w).

2. The kit of claim 1, wherein the kit contains a mixing element.

3. The kit of claim 1, wherein the at least one inactive agent is an anti-foaming agent.

4. The kit of claim 3, wherein compounded pharmaceutical contains an anti-foaming agent in an amount selected from the group consisting of 0.01%, 0.05%, 0.1%, 5% and 10% (w/w).

5. The kit of claim 4, wherein the anti-foaming agent is simethicone.

6. The kit of claim 1, wherein the at least one inactive agent is a suspending agent.

7. The kit of claim 6, wherein the suspending agent is propylene glycol.

8. The kit of claim 1, wherein the active agent is testosterone and the at least one inactive agent is petrolatum.

9. The kit of claim 1, wherein the compounded pharmaceutical is 2% testosterone in petrolatum.

10. The kit of claim 1, wherein the active agent is hydrocortisone and the at least one inactive agent is ultrasound gel and an anti-foaming agent.

11. The kit of claim 1, wherein the compounded pharmaceutical is 10% hydrocortisone in ultrasound gel and 0.1-5% anti-foaming agent (w/w).

12. The kit of claim 1, wherein the active agents are triamcinolone and coal tar.

13. The kit of claim 12, wherein the at least one inactive agent is coal tar.

14. The kit of claim 1, wherein the compounded pharmaceutical is 0.1% triamcinolone with 10% coal tar.

15. The kit of claim 1, wherein the active agent is ketoprofen and the at least one inactive agent is PLO gel.

16. The kit of claim 1, wherein the compounded pharmaceutical is 10% ketoprofen in PLO gel.

17. The kit of claim 1, wherein the compounded pharmaceutical is 20% ketoprofen in PLO gel.

18. The kit of claim 1, wherein the active agents are estrone, estradiol and progesterone and the at least one inactive agent is lactose.

19. The kit of claim 1, wherein the active agents are estriol, estrone, estradiol and progesterone and the at least one inactive agent is lactose.

20. The kit of claim 1, wherein the active agent is scopolamine and the at least one inactive agent is PLO gel.

21. The kit of claim 1, wherein the compounded pharmaceutical is 5% scopolamine in PLO gel.

22. The kit of claim 1, wherein the active agent is promethazine and the at least one inactive agent is PLO gel.

23. The kit of claim 1, wherein the compounded pharmaceutical is 5% promethazine in PLO gel.

24. The kit of claim 1, wherein the active agents are diphenhydramine hydrochloride and magnesium hydroxide/aluminum hydroxide.

25. The kit of claim 1, wherein the active agents are diphenhydramine hydrochloride, magnesium hydroxide/aluminum hydroxide and lidocaine HCl.

26. The kit of claim 1, wherein the active agents are diphenhydramine hydrochloride, magnesium hydroxide/aluminum hydroxide and nystatin.

27. The kit of claim 1, wherein the active agents are lidocaine, adrenaline and tetracaine.

28. The kit of claim 1, wherein the active agent is progesterone and the at least one inactive agent is PLO gel.

29. The kit of claim 1, wherein the active agent is diclofenac and the at least one inactive agent is PLO gel.

30. The kit of claim 1, further comprising a package housing the first container and the second container and the instructions.

31. The kit of claim 1, wherein a second inactive agent is present in the first container.

32. The kit of claim 31, further comprising a third inactive agent in the second container.

33. The kit of claim 1, wherein a second inactive agent is present in the second container.

34. The kit of claim 33, further comprising a third inactive agent in the first container.

35. The kit of claim 1, wherein the active agent is testosterone and the at least one inactive agent is cream.

36. The kit of claim 1, wherein the compounded pharmaceutical is 2% testosterone in cream.

37. The kit of claim 1, wherein the active agent is progesterone and the at least one inactive agent is cream.

38. The kit of claim 1, wherein the compounded pharmaceutical is 10% progesterone in cream.

39. The kit of claim 1, wherein the estrogen is selected from the group consisting of one estrogen, a two estrogen combination, and a three estrogen combination.

40. The kit of claim 1, wherein the at least one inactive agent is an alcohol.

41. A kit for compounding pharmaceuticals comprising:

a first container comprising an active agent and optionally comprising a second inactive agent,

a second container comprising at least one inactive agent, and

instructions for use,

wherein the active agent and the at least one inactive agent each is pre-measured into a respective unit of use amount,

wherein the at least one inactive agent occupies a volume in the second container equal to or less than the volume of the container minus the volume of the active agent,

wherein a mixture of the active agent and the at least one inactive agent comprises a compounded pharmaceutical selected from the group consisting of testosterone and petrolatum, hydrocortisone and ultrasound gel and anti-foaming agent, triamcinolone and coal tar, ketoprofen and PLO gel, progesterone and cream, progesterone and PLO gel, diclofenac and PLO gel, testosterone and cream, testosterone and ointment, promethazine and PLO gel, scopolamine and PLO gel, estrogen in lactose, estrogen and progesterone in lactose, magnesium hydroxide/aluminum hydroxide and diphenhydramine hydrochloride, magnesium hydroxide/aluminum hydroxide and diphenhydramine hydrochloride and nystatin, magnesium hydroxide/aluminum hydroxide and diphenhydramine hydrochloride and lidocaine-HCl, and lidocaine, adrenaline and tetracaine (LAT), and

the anti-foaming agent is present in an amount of 0.01-10% (w/w).

42. The kit of claim 41, wherein the estrogen is selected from the group consisting of one estrogen, a two estrogen combination, and a three estrogen combination.

43. The kit of claim 41, wherein the compounded pharmaceutical is 10% hydrocortisone in ultrasound gel and 0.1-5% anti-foaming agent (w/w).

44. The kit of claim 41, wherein compounded pharmaceutical contains an anti-foaming agent in an amount selected from the group consisting of 0.01%, 0.05%, 0.1%, 5% and 10% (w/w).

45. The kit of claim 41, wherein the at least one inactive agent is an alcohol.