Compositions and kits for compounding pharmaceuticals

• US 20040191276A1
• Filed: 02/26/2004
• Published: 09/30/2004
• Est. Priority Date: 11/30/1999
• Status: Abandoned Application

• Current Assignee: Cutispharma, Inc. (Azurity Pharmaceuticals, Inc.)
• Original Assignee: Cutispharma, Inc. (Azurity Pharmaceuticals, Inc.)
• Inventors: Muni, Indu A.
• Application Number:
  US10/787,546
• Publication Number:
  US 20040191276A1
• Time in Patent Office: Days
• US Class Current: 424/400
• 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 3/00 Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/04 Nitro compounds
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/138 Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• 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 31/245 Amino benzoic acid types, e.g. procaine, novocaine salicylic acid esters A61K31/60
• 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 31/566 having an oxo group in position 17, e.g. estrone
• 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 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 33/08 Oxides; Hydroxides
• 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 47/24 : containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
• 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

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 active agent or 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 or inactive 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 Dexamethasone in distilled water;

Dexamethasone in saline;

Dexamethsone in ultrasound gel;

Nitroglycerin in white petrolatum;

Nitroglycerin in cream;

Estriol in moisturizing cream;

Estriol in capsule;

Estriol in a gel including PLO;

Estradiol in moisturizing cream;

Estradiol in capsule;

Estradiol in gel including PLO;

Estrone in moisturizing cream;

Estrone in capsule;

Estrone in gel including PLO;

Fluconazole in topical solution;

Progesterone in cream;

Progesterone in ointment;

Progesterone in gel including PLO;

Progesterone in vaginal suppositories;

Progesterone in capsule;

Indomethacin in appropriate base for suppositories;

Boric acid in appropriate base for suppositories;

Morphine in appropriate base for suppositories;

Mesalamine in appropriate base for suppositories;

Hydrocortisone in appropriate base for suppositories;

Ketamine in gel including PLO;

Ibuprofen in gel including PLO;

Diclofenac in cream;

Diclofenac in gel including PLO;

Testosterone in cream;

Testosterone in ointment;

Testosterone in capsule;

Testosterone in gel including PLO;

Promethazine in cream;

Promethazinein gel including PLO;

Promethazine in ointment;

Chloramphenicol in ointment;

Chloramphenicol in cream;

Brompheniramine in oral liquid;

Tetracycline in topical solution;

Dexamethasone in cream;

Zinc oxide in gel;

Zinc oxide in ointment;

Hydrocortisone in cream;

Hydrocortisone in ointment;

Hydrocortisone in gel including ultrasound gel;

Cholestyramine in cream;

Cholestyramine in ointment;

Ketoprofen in cream;

Ketoprofen in ointment;

Ketoprofen in gel including PLO;

Scopolamine in cream;

Scopolamine in gel including PLO;

Omeprazole in sodium bicarbonate solution;

Omeprazole in sodium bicarbonate suspension;

Enteric coated omeprazole in suspension;

Enteric coated omeprazole in solution;

Triamcinolone in cream;

Triamcinolone in coal tar, Triamcinolone in ointment;

Triamcinolone in gel;

Sulfadiazine in cream;

Sulfadiazine in suspension;

Metronidazole in suspension;

Metronidazole benzoate in suspension;

Salicylic acid in cream;

Salicylic acid in gel;

Salicylic acid in ointment;

Salicylic acid in coal tar;

Captopril in suspension;

Verapamil in suspension;

Rifampin in suspension;

Propanolol in suspension;

Potassium acetate in solution;

Methimazole in suspension;

Indomethacin in suspension;

Enalapril in suspension;

Dapsone in suspension;

Azathioprine in suspension;

Amitryptyline in suspension;

Allopurinol in suspension;

Acetazolamide in suspension;

Ganciclovir in suspension;

Fludrocortisone in suspension;

Flucytosine in suspension;

Flecainide in suspension;

Cisapride suspension;

Ciprofloxacin in suspension;

Carbamazapine in suspension;

Bethanechol in suspension;

Baclofen in suspension;

Potassium bromide capsules;

Potassium bromide solutions;

Potassium citrate capsules;

Potassium citrate solutions;

Sodium bromide capsules;

Sodium bromide solutions;

Sodium citrate capsules;

Sodium citrate solutions;

Acetylcystin solution;

Acetylcystin suspension;

Tetracycline(s) in suspension;

Diazepam suspension;

Diazepam solution;

Atropine solution;

Prednisolone solution;

Prednisolone suspension;

Atenolol capsules;

Atenolol solutions;

Apomorphine capsules;

Apomorphine solutions;

Urosidol capsules;

Urosidol suspension;

Calcitrol capsules;

Calcitrol solutions;

Aluminum carbonate capsules;

Hydrocortisone in suspension;

Levothyroxine in suspension.

2. The kit of claim 1, wherein the active agent is selected from the group consisting of Dexamethasone;

Nitroglycerin;

Estriol;

Estradiol;

Estrone;

Fluconazole;

Progesterone;

Indomethacin;

Boric acid;

Morphine;

Mesalamine;

Hydrocortisone;

Promethazine;

Triamcinolone;

Coal Tar;

Ketamine;

Ibuprofen;

Diclofenac;

Testosterone;

Chloramphenicol;

Brompheniramine;

Tetracycline;

Zinc oxide;

Cholestyramine;

Ketoprofen;

Scopolamine;

Omeprazole;

Sulfadiazine;

Metronidazole;

Metronidazole benzoate;

Salicylic acid;

Captopril;

Verapamil;

Rifampin;

Propanolol;

Potassium acetate;

Methimazole;

Enalapril;

Dapsone;

Azathioprine;

Am itryptyline;

Al lopurinol;

Acetazolamide;

Ganciclovir;

Fludrocortisone;

Flucytosine;

Flecainide;

Cisapride;

Ciprofloxacin;

Carbamazapine;

Bethanechol;

Baclofen;

Potassium bromide;

Potassium citrate;

Sodium bromide;

Sodium citrate;

Acetylcystin;

Diazepam;

Atropine;

Prednisolone;

Atenolol;

Apomorphine;

Urosidol;

Calcitrol;

Aluminum carbonate;

Lidocaine;

Adrenaline;

Tetracaine;

Magnesium hydroxide/aluminum hydroxide;

Diphenhydramine hydrochloride;

Nystatin;

Chlorhexidine and Levothyroxine.

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

4. The kit of claim 1, wherein the active agent and the at least one inactive agent or second active agent are physically mixed by a pharmacist, pharmacist assistant, or physician to produce a compounded pharmaceutical composition.

5. The kit of claim 1, wherein a container is selected from the group consisting of ajar, a pouch, a packet, a vial, a tube, a bottle, or a suitable pharmaceutical container.

6. A kit for compounding pharmaceuticals comprising:

a first container comprising a first active agent,

a second container comprising at least one second active agent, and

instructions for use.

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

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

wherein a mixture of the first active agent and the at least one second active agent comprises a compounded pharmaceutical selected from the group consisting of Estriol;

Estradiol;

Estrone in moisturizing cream;

Estriol;

Estradiol;

Estrone in capsules;

Estriol;

Estradiol;

Estrone in gel including PLO;

Estriol;

Estradiol in moisturizing cream;

Estriol;

Estradiol in capsules;

Estriol;

Estradiol in gel including PLO;

Tri-Estrogen drops;

Estradiol;

Progesterone in capsules;

Estradiol;

Progesterone in cream;

Estradiol;

Progesterone in gel;

Estradiol;

Testosterone in capsules;

Estradiol;

Testosterone in cream;

Estradiol;

Testosterone in gel including PLO;

Ketamine/Amitryptyline in ointment;

Ketamine/Amitryptyline in cream;

Ketamine/Amitryptyline in gel including PLO;

Clonidine/Gabapentin/Ketamine in gel including PLO;

Lidocaine/Nystatin/Zinc oxide in cream;

Lidocaine/Nystatin/Zinc oxide in ointment;

Lidocaine/Nystatin/Zinc oxide in gel;

Lidocaine/Phenytoin in cream;

Lidocaine/Phenytoin in ointment;

Hydrocortisone/Lidocaine in cream;

Hydrocortisone/Lidocaine in suppositories;

Hydrocortisone/Lidocaine in suspension;

Hydrocortisone/Lidocaine in gel including ultrasound gel;

Bi-Estrogen/Progesterone in capsules;

Bi-Estrogen/Progesterone in cream;

Bi-Estrogen/Progesterone in gel including PLO;

Bi-Estrogen/Testosterone in capsules;

Bi-Estrogen/Testosterone in cream;

Bi-Estrogen/Testosterone in gel including PLO;

Tri-Estrogen/Progesterone in capsules;

Tri-Estrogen/Progesterone in cream;

Tri-Estrogen/Progesterone in gel including PLO;

Tri-Estrogen/Testosterone in capsules;

Tri-Estrogen/Testosterone in cream;

Tri-Estrogen/Testosterone in gel including PLO;

Estradiol/Progesterone in solution ;

Estradio/Testosterone in solution;

Dexamethsone/Lidocaine in gel;

Dexamethsone/Lidocaine in solution;

Salicylic acid/Triamcinolone Acetonide/Coal Tar;

Salicylic acid/coal tar, Triamcinolone Acetonide/coal tar;

Triamcinolone Acetonide/coal tar/salicylic acid/sulfur;

Diphenhydramine hydrochloride /Lidocaine/ Magnesium hydroxide/aluminum hydroxide;

diphenhydramine hydrochloride /Lidocaine/Nystatin;

Diphenhydramine hydrochloride /Lidocaine/ Magnesium hydroxide/aluminum hydroxide /Nystatin;

Diphenhydramine hydrochloride /Lidocaine/ Magnesium hydroxide/aluminum hydroxide /Nystatin/ Chlorhexidine;

Diphenhydramine hydrochloride /Hydrocortisone/Nystatin;

Diphenhydramine hydrochloride /Lidocaine/Tetracycline;

Lidocaine/Adrenaline/Tetracaine;

or any combination of, Magnesium hydroxide/aluminum hydroxide, Nystatin, Lidocaine, Hydrocortisone, Tetracycline, Diphenhydramine hydrochloride, and Chlorhexidine.

7. The kit of claim 6, wherein the kit contains a mixing element.

8. The kit of claim 6, wherein the active agent and the at least one inactive agent or second active agent are physically mixed by a pharmacist, pharmacist assistant, or physician to produce a compounded pharmaceutical composition.

9. The kit of claim 6, wherein a container is selected from the group consisting of ajar, a pouch, a packet, a vial, a tube, a bottle, or a suitable pharmaceutical container.