Therapeutic methods utilizing naturally derived bio-active complexes and delivery systems therefor

• US 6,303,588 B1
• Filed: 01/12/1999
• Issued: 10/16/2001
• Est. Priority Date: 12/06/1994
• Status: Expired due to Fees

• Current Assignee: Michael M. Danielov
• Original Assignee: Michael M. Danielov
• Inventors: Danielov, Michael M.
• Primary Examiner(s): Criares, Theodore J.
• Application Number:
  US09/228,384
• Time in Patent Office: 1,008 Days
• Field of Search: 514/109, 514/305, 514/103, 514/724, 514/167, 514/171, 514/573, 514/182
• US Class Current: 514/109
• CPC Class Codes: A61K 2800/70 Biological properties of the composition as a whole
• CPC Class Codes: A61K 38/22 Hormones derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 8/068 Microemulsions
• CPC Class Codes: A61K 8/365 Hydroxycarboxylic acids; Ketocarboxylic acids
• CPC Class Codes: A61K 8/49 containing heterocyclic compounds
• CPC Class Codes: A61K 8/553 Phospholipids, e.g. lecithin
• CPC Class Codes: A61K 8/606 Nucleosides; Nucleotides; Nucleic acids
• CPC Class Codes: A61K 8/63 Steroids; Derivatives thereof
• CPC Class Codes: A61K 8/64 Proteins; Peptides; Derivatives or degradation products thereof
• CPC Class Codes: A61K 8/65 Collagen; Gelatin; Keratin; Derivatives or degradation products thereof
• CPC Class Codes: A61K 8/67 Vitamins
• CPC Class Codes: A61K 8/673 Vitamin B group
• CPC Class Codes: A61K 8/675 Vitamin B3 or vitamin B3 active, e.g. nicotinamide, nicotinic acid, nicotinyl aldehyde tocopheryl nicotinate A61K8/678
• CPC Class Codes: A61K 8/678 Tocopherol, i.e. vitamin E
• CPC Class Codes: A61K 9/1275 Lipoproteins; Chylomicrons; Artificial HDL, LDL, VLDL, protein-free species thereof; Precursors thereof
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin
• CPC Class Codes: A61Q 19/007 Preparations for dry skin
• CPC Class Codes: A61Q 19/008 Preparations for oily skin
• CPC Class Codes: A61Q 19/04 for chemically tanning the skin topical sun or radiation screening or tanning preparations A61Q17/04

Abstract

Methods are disclosed for correcting biological information transfer in a patient in need of such therapy which comprise administration to a patient of a composition comprising a therapeutically effective amount of a biocomplex comprising at least one bioactive agent from each of the three informational blocks of biological information transfer, each agent being present in an amount sufficient to correct the biological information transfer of the patient under treatment and resulting in the resumption of normal cell metabolism, said amount being less than the buffering amount of said agent; together with a carrier therefor.

Claims

1. A method for treating the skin of a patient with abnormal skin cell metabolism to correct the abnormal skin cell metabolism and promote the resumption of normal skin cell metabolism comprising applying to the portions of the skin of such patient which have abnormal skin cell metabolism a composition containing a bioactive agent and a biologically acceptable carrier therefor, the amount of the bioactive agent being sufficient to correct the abnormal skin cell metabolism but less than the buffering amount of said agent, wherein the composition comprises:

adenosine-5-triphosphate;

guanosine-5-triphosphate;

phosphoinositedes containing;

1) 15-20% phosphatidylinositol 4,5-diphosphate and phosphatidylinositol 4-monophosphate;

2) the remainder is a mixture of phosphatidylinositol and phosphatidylserine;

Type I brain exract containing 10-20% phosphatidylinosides, 50-60% phosphatidylserines;

adenosine 3′

5′

-cyclic monophosphate sodium salt;

guanosine 3′

5′

-cyclic monophosphate;

d-myo-Inositol triphosphate; and

calmodulin.

2. The method of claim 1 wherein the composition comprises by weight per 1 kg of formulated product:

1-50 mg adenosine-5-tiphosphate;

1-30 mg guanosine-5-triphosphate;

10-100 μ

g phosphoinositedes containg;

1) 15-20% phosphotidyl inositol 4,5-diphosphate and phosphatidylinositol 4-monophosphate;

2) the remainder is a mixture of phosphatidylinositol and phosphotidylserine;

0.5-10 mg Type 1 brain extract containing 10-20% phosphatidyhinosilides, 50-60% phosphatidylserines;

1-10 mg adenosine 3′

5′

-cyclic monophosphate sodium salt;

0.1-5 mg guanosine 3′

5′

-cyclic monophosphate;

1-66 μ

g d-myo-Inositol triphosphate; and

1-20 μ

g calmodulin.

3. The method of claim 1 wherein the composition also comprises at least one component selected from the group consisting of adrenocorticotropic hormone;

β

-lipotropin;

β

-endotphin;

somatotropin;

follicle-stimulatirng hormone;

luteinizing hormone;

thyrotropic hormone;

vasopressin;

patathyroid hormone;

thyrocalcitonin;

angiotensin II;

glucagon;

vasoactive intestinal peptide;

gastric inhibitory polypeptide; and

insulin.

4. The method of claim 3 wherein the components listed in claim 3, when present in the composition, comprise by weight per 1 kg of formulated product:

2-120 ng adrenocorticotropic hormone;

1-10 μ

β

-lipotropin β

-endorphin;

1-10 μ

g somatotropin;

0.01-1.0 μ

g follicle-stimulating hormone;

0.05-0.5 μ

g luteinizing hormone;

0.05-0.15 μ

g thyrotropic hormone;

0.02-1.0 μ

g vasopressin;

0.5-2.0 parathyroid hormone;

20-120 ng vasoactive intestinal peptide; and

0.5-5 μ

g insulin.

5. The method of claim 1 wherein the composition also comprises at least one component selected from the group consisting of hydrocortisone;

corticosterone-21-sulfate;

progesterone;

β

-estradiol;

estriol-3-sulfate sodium salt;

cholecalciferol sulfate;

epinephrine hydrochloride;

arterenol hydrochloride; and

aldosterone.

6. The method of claim 5 wherein the components listed in claim 5, when present in the composition, comprise by weight per 1 kg of formulated product:

25-250 μ

g hydrocortisone;

1-30 μ

g corticosterone-21-sulfate;

2-10 μ

g progesterone;

50-500 ng β

-estradiol;

200-700 ng estriol-3-sulfate sodium salt;

200-700 ng epinephrine hydrochloride;

300-900 ng arterenol hydrochloride; and

10-600 ng α

-aldosterone-21-hemisuccinate.

7. The method of claim 1 wherein the composition also comprises at least one component selected from the group consisting of prostaglandin D₂, prostaglandin E₁, prostaglandin E₂, prostaglandin F_2α

and prostaglndin I₂.

8. The method according to claim 7 wherein the components listed in claim 7, when present in the composition, comprise by weight per 1 kg of formulated product:

1-5 μ

g prostaglandin D₂,

1-5 μ

g prostaglandin E₁,

1-5 μ

g prostaglandin E₂,

0.5-3 μ

g prostaglandin F_2α

, and

1-5 μ

g prostaglandin I₂.

9. A method for treating the skin of a patient with abnomial skin cell metabolism to correct the abnormal skin cell metabolism and promote the resumption of normal skin cell metabolism comprising applying to the portions of the skin of such patient which have abnormal skin cell metabolism a composition containing a bioactive agent and a biologically acceptable carrier therefor, the amount of the bioactive agent being sufficient to correct the abnormal skin cell metabolism but less than the buffering amount of said agent, wherein the composition comprises:

adenosine-5-triphosphate;

guanosine-5-triphosphate;

phosphoinositedes containing;

1) 15-20% phosphotidyl inositol 4,5-diphosphate and phosphatidylinositol 4-monophosphate;

2) the remainder is a mixture of phosphotidylinositol and phosphotidylserine;

Type I brain extract containing 10-20% phosphotidylinosilides, 50-60% phosphatidylserines, and other brain lipids;

adenosine 3′

5′

-cyclic monophosphate sodium salt;

guanosine 3′

5′

-cyclic monophosphate;

d-myo-Inositol triphosphate;

protein kinase;

coenzyme A;

β

-nicotinamide adenine dinucleotide;

β

-nicotinamide adenine dinucleotide phosphate; and

calmodulin;

wherein the composition further comprises a protein-peptide biocomplexbioactive agent selected from the group comprising somatotropin;

follicle-stimulating hormone;

luteinizig hormone;

vasopressin;

thyrocalcitonin;

angiotensin;

glucagon;

vasoactive intestinal peptide;

gastric inhibitory polypeptide; and

mixtures thereof;

wherein the composition further comprises a second bioactive agent selected from the group comprising hydrocortisone;

corticosterone-21-sulfate;

progesterone;

β

-estradiol;

estriol-3-sulfate sodium salt;

epinephrine hydrochloride;

arterenol hydrochloride;

aldosterone and mixtures thereof; and

wherein the composition further comprises a third bioactive agent selected from the group comprising prostaglandin D₂, prostaglandin E₁, prostaglandin E₂, prostaglandin F_2α

prostaglandin I₂, and mixtures thereof.