METHOD FOR SYSTEMIC DRUG DELIVERY THROUGH THE NAIL

• US 20110238003A1
• Filed: 04/29/2011
• Published: 09/29/2011
• Est. Priority Date: 02/12/2002
• Status: Abandoned Application

• Current Assignee: Novartis Ag
• Original Assignee: Novartis Ag
• Inventors: Karabelas, Argeris Jerry, Bruno-Raimondi, Alfredo Emilio
• Application Number:
  US13/097,896
• Publication Number:
  US 20110238003A1
• Time in Patent Office: Days
• US Class Current: 604/22
• CPC Class Codes: A61B 18/203 applying laser energy to the outside of the body
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61K 9/70 Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug hollow drug-filled fibres A61K9/0092
• CPC Class Codes: A61P 1/08 for nausea, cinetosis or vertigo; Antiemetics
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 15/18 Feminine contraceptives
• CPC Class Codes: A61P 23/00 Anaesthetics
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/06 Antimigraine agents
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 25/34 Tobacco-abuse
• 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 29/02 without antiinflammatory effect
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/06 : for tuberculosis
• CPC Class Codes: A61P 31/12 : Antivirals
• CPC Class Codes: A61P 31/14 : for RNA viruses
• CPC Class Codes: A61P 31/16 : for influenza or rhinoviruses
• CPC Class Codes: A61P 31/18 : for HIV
• CPC Class Codes: A61P 31/20 : for DNA viruses
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 39/00 : General protective or antinoxious agents
• CPC Class Codes: A61P 5/26 : Androgens
• CPC Class Codes: A61P 5/30 : Oestrogens
• CPC Class Codes: A61P 9/12 : Antihypertensives
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

A method for systemically delivering a pharmaceutical composition to a human or animal, said method comprising forming an orifice in a nail of a human or animal by means of a laser-based device and applying a pharmaceutical composition in the orifice, wherein said method provides a controlled release of the pharmaceutical composition.

Claims

1. A method for systemically delivering a pharmaceutical composition to a human or animal, said method comprising forming one or more orifices in a nail of the human or animal and applying the pharmaceutical composition in the orifice.

2. A method according to claim 1 wherein the orifices are formed by means of a laser.

3. A method according to claim 1 which provides a controlled release of the pharmaceutical composition.

4. The method according to claim 3 wherein the laser is selected from the group consisting of a Erbium:

YAG laser, a Nd;

YAG laser, an OPO laser, a Ho;

YAG laser, a CO2 laser, a UV laser, an excimer laser, and combinations thereof.

5. The method according to claim 1 wherein a protective layer is placed on the outer surface of the orifice covering the nail.

6. The method according to claim 1 wherein the pharmaceutical composition comprises at least one active ingredient.

7. The method according to claim 6 wherein the active ingredient is a vaccine.

8. The method according to claim 7 wherein the vaccine is selected from the group consisting of Smallpox, Rabies, Plaque, Diphteria, Pertussis, Tuberculosis, Tetanus, Yellow Fever, Injectable Polio Vaccine, Oral Polio Vaccine, Measales, Mumps, Rubella, Hepatitis B, Hepatitis C, Haemophilus influenza Typ B, Japanese Encephalitis, Biomanguinhos, Hib, HIV and cancer.

9. The method according to claim 7 wherein the vaccine requires multiple inoculation to achieve protective titers such as Hepatitis B and Hepatitis C.

10. The method according to claim 7 wherein the vaccine requires long contact with dendritic cells to achieve a cytotoxic T-cell response.

11. The method according to claim 10 wherein the cancer vaccine comprises whole tumor cells or of substances contained by the tumor.

12. The method according to claim 10 wherein the cancer vaccine is selected from the group consisting of whole cancer cells, peptides, proteins, dendritic cells, gangliosids, heat-shock proteins, viral and bacterial vectors and nucleic acids.

13. The method according to claim 6 wherein the active ingredient is selected from the group consisting of a photosensitizer, androgen, estrogen, nonsteroidal anti-inflammatory agent, antihypertensive agent, analgesic agent, antidepressant, antibiotic, anticancer agent, anesthetic, antiemetic, antiinfectant, contraceptive, antidiabetic agent, steroid, anti-allergy agent, anti-migraine agent, agent for smoking cessation, and anti-obesity agent.

14. The method according to claim 6 wherein the active ingredient is selected from the group consisting of acebutolol, acetylcysteine, acetaminophen, acetylsalicylic acid, acyclovir, alprazolam, alfacalcidol, allantoin, allopurinol, aloe vera, ambroxol, amikacin, amiloride, aminoacetic acid, amiodarone, amitriptyline, amlodipine, amoxicillin, ampicillin, ascorbic acid, astemizole, atenolol, beclomethasone, bee propolis, benserazide, benzalkonium hydrochloride, benzocaine, betamethasone, bezafibrate, biotin, biperiden, bisoprolol, bromazepam, bromhexine, bromocriptine, budesonide, bufexamac, buflomedil, bupivacaine, buspirone, caffeine, camphor, captopril, carbamazepine, carbidopa, carboplatin, cefachlor, cefalexin, cefatroxil, cefazolin, cefixime, cefotaxime, ceftazidime, ceftriaxone, cefuroxime, selegiline, chloramphenicol, chlorhexidine, chlor-pheniramine, chlortalidone, choline, cyclosporin, cilastatin, cimetidine, ciprofloxacin, cisapride, cisplatin, clarithromycin, clavulanic acid, clomidine, clomipramine, clonazepam, clonidine, clotrimazole, codeine, cholestyramine, cromoglycic acid, cyanocobalamin, cyproterone, desogestrel, dexamethasone, dexpanthenol, dexamethasone, dextromethorphan, dextropropoxiphen, diazepam, diclofenac, digoxin, dihydrocodeine, dihydroergotamine, dihydroergotoxin, diltiazem, diphenhydramine, dipyridamole, dipyrone, disopyramide, domperidone, dopamine, doxycycline, enalapril, ephedrine, epinephrine, ergocalciferol, ergotamine, erythromycin, estradiol, ethinylestradiol, etoposide, Eucalyptus globulus, famotidine, felodipine, fenofibrate, fenoterol, fentanyl, flavin mononucleotide, fluconazole, flunarizine, fluorouracil, fluoxetine, flurbiprofen, folic acid, folinic acid, furosemide, gallopamil, gemfibrozil, gentamicin, Gingko biloba, glibenclamide, glipizide, clozapine, Glycyrrhiza glabra, griseofulvin, haloperidol, heparin, hyaluronic acid, hydrochlorothiazide, hydrocodone, hydrocortisone, hydromorphone, ipratropium hydroxide, ibuprofen, imipenem, indomethacin, insulin, iohexol, iopamidol, isosorbide dinitrate, isosorbide mononitrate, isotretinoin, ketotifen, ketoconazole, ketoprofen, ketorolac, labetalol, lactulose, levocarnitine, levodopa, levoglutamide, levonorgestrel, levothyroxine, lidocaine, lipase, imipramine, lisinopril, loperamide, lorazepam, lovastatin, medroxyprogesterone, menthol, methotrexate, methyldopa, methylprednisolone, metoclopramide, metoprolol, miconazole, midazolam, minocycline, minoxidil, misoprostol, morphine, multivitamin mixtures and combinations and mineral salts, N-methylephedrine, naftidrofuryl, naproxen, neomycin, nicardipine, nicergoline, nicotinamide, nicotine, nicotinic acid, nifedipine, nimodipine, nitrazepam, nitrendipine, nitroglycerine, nizatidine, norethisterone, norfloxacin, norgestrel, nortriptyline, nystatin, ofloxacin, omeprazole, ondansetron, pancreatin, panthenol, pantothenic acid, paracetamol, penicillin G, penicillin V, phenobarbital, pentoxifylline, phenoxymethylpenicillin, phenylephrine, phenylpropanolamine, phenytoin, piroxicam, polymyxin B, povidone-iodine, pravastatin, prazepam, prazosin, prednisolone, prednisone, prilocaine, progesterone, propafenone, propranolol, proxyphylline, pseudoephedrine, pyridoxine, quinidine, ramipril, ranitidine, reserpine, retinol, riboflavin, rifampicin, rutoside, salbutamol, salcatonin, salicylic acid, scopolamine, simvastatin, somatotropin, sotalol, spironolactone, sucralfate, sufentanil, sulbactam, sulfamethoxazole, sulfasalazine, sulpiride, sumatriptan, tamoxifen, tegafur, teprenone, terazosin, terbutaline, terfenadine, testosterone, tetracaine, tetracycline, theophylline, thiamine, ticlopidine, timolol, tranexamic acid, tretinoin, triamcinolone acetonide, triamterene, trimethoprim, troxerutin, uracil, valproic acid, vancomycin, verapamil, vitamin A, vitamin C, vitamin E, and zidovudine.

15. The method according to claim 1 wherein the pharmaceutical composition is in a form which is selected from the group consisting of a liquid, semi-solid, solid, solution, gel, emulsion, and powder.

16. The method according to claim 6 wherein the active ingredient is present in the pharmaceutical composition in an amount of from 0.1 weight percent, based on the total weight of the pharmaceutical composition, to 100 weight percent.

17. The method according to claim 16 wherein the amount of active ingredient is from 20 to 80 weight percent, based on the total weight of the pharmaceutical composition.

18. The method according to claim 17 wherein the amount of active ingredient is from 30 to 70 weight percent, based on the total weight of the pharmaceutical composition.

19. The method according to claim 1 which is carried out using a laser-based device comprising a laser and at least one element selected from the group consisting of a support, a computer controlled xyz translation stage module, a mirror, an optical focusing element comprising at least one lens, a computer, a video camera, a charged coupled device camera, a feedback sensor, and an optical element.

20. The method according to claim 1 wherein the diameter of the orifice is from 1 μ

m (micron) to 1 mm.

21. The method according to claim 20 wherein the diameter of the orifice is from 50 μ

m (microns) to 200 μ

pm (microns).

22. The method according to claim 21 wherein the diameter of the orifice is from 50 μ

m (microns) to 100 μ

m (microns).