PHARMACEUTICAL PREPARATIONS FOR ATTENTION DEFICIT DISORDER, ATTENTION DEFICIT HYPERACTIVITY DISORDER AND OTHER ASSOCIATED DISORDERS

• US 20070116695A1
• Filed: 09/21/2006
• Published: 05/24/2007
• Est. Priority Date: 09/21/2005
• Status: Abandoned Application

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan
• Application Number:
  US11/533,818
• Publication Number:
  US 20070116695A1
• Time in Patent Office: Days
• US Class Current: 424/94.200
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• 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 31/37 Coumarins, e.g. psoralen
• CPC Class Codes: A61K 38/465 acting on ester bonds (3.1), e.g. lipases, ribonucleases
• CPC Class Codes: A61K 38/47 acting on glycosyl compounds (3.2), e.g. cellulases, lactases
• CPC Class Codes: A61K 38/48 acting on peptide bonds (3.4)
• CPC Class Codes: A61K 38/4826 Trypsin (3.4.21.4) Chymotrypsin (3.4.21.1)
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00
• CPC Class Codes: C12Y 304/21001 Chymotrypsin (3.4.21.1)

Abstract

A pharmaceutical preparation for the treatment of attention deficit disorders combines a therapeutically effective amount of digestive enzymes, such as chymotrypsin, and medication used to treat attention deficit disorders, such as Ritalin®, Concert®, Adderall® and Strattera®. The preparation may be in the form of a tablet, capsule or time released formula in order to reduce the amount of pills per dosage. The pharmaceutical preparation ameliorates the symptoms of the attention deficit disorder. The preparation has a stabilizing matrix containing a solidified microcrystalline cellulose which captures and protects therapeutically effective amounts of digestive enzyme particles within the stabilizing matrix.

Claims

1. A pharmaceutical preparation to treat attention deficit disorders in an individual comprising a therapeutically effective amount of a medication used to treat attention deficit disorders and a therapeutically effective amount of digestive enzymes.

2. The pharmaceutical preparation of claim 1, wherein the medication used to treat attention deficit disorders is selected from the group consisting of methylphenidate, methylphenidate HCl, amphetamine, amphetamine salts, atomoxetine HCl, and a combination thereof.

3. The pharmaceutical preparation of claim 1, wherein the digestive enzyme is selected from the group consisting of:

amylase, lipase, protease, cellulase, bromelain, chymotrypsin, trypsin, carboxypeptidase, elastase, hydrolase, pancreatin, papaya, papain, and a combination thereof.

4. The pharmaceutical preparation of claim 1, wherein the enzymes are derived from a source selected from the group consisting of animal enzymes, plant enzymes, synthetic enzymes, and a combination thereof.

5. The pharmaceutical preparation of claim 1, wherein the amount of methylphenidate ranges from 1 mg to 30 mg.

6. The pharmaceutical preparation of claim 1, wherein the amount of methylphenidate HCL ranges from 2.5 to 32 mg.

7. The pharmaceutical preparation of claim 1, wherein the amount of amphetamine ranges from 3.1 mg to 18.8 mg.

8. The pharmaceutical preparation of claim 1, wherein the amount of atomoxetine HCl ranges from 5 mg to 100 mg.

9. The pharmaceutical preparation of claim 1, wherein the digestive enzyme is chymotrypsin.

10. The pharmaceutical preparation of claim 1 wherein the preparation is manufactured using a technology selected from the group consisting of Prosolv technology, enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation, and a combination thereof.

11. The pharmaceutical preparation of claim 1, wherein the preparation is administered orally via a dosage formulation selected from the group consisting of:

pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, and a combination thereof.

12. The pharmaceutical preparation of claim 1, wherein the preparation is resistant to degradation by an environmental factor selected from the group consisting of light, heat, humidity, association with an excipient, and a combination thereof.

13. The pharmaceutical preparation of claim 12 wherein the excipient provides a matrix to capture and protect the product before delivery.

14. The pharmaceutical preparation of claim 1, wherein the individual taking the preparation is able to reduce the amount of ADHD medication taken.

15. The pharmaceutical preparation of claim 1, wherein primary and secondary symptoms of the attention deficit disorder are ameliorated.

16. The pharmaceutical preparation of claim 1 wherein the primary symptoms of the attention deficit disorder are selected from the group consisting of lack of attention span, impulsiveness, hyperactivity, and a combination thereof.

17. The pharmaceutical preparation of claim 1 wherein the primary symptoms of the attention deficit disorder are selected from the group consisting of such as an inability to digest protein, gastrointestinal disorders, decreased appetite, insomnia, and a combination thereof.

18. A method for the manufacture of a pharmaceutical preparation by direct compression comprising the steps of:

forming an active blend by blending an intimate admixture of silicified microcrystalline cellulose and a therapeutic agent comprising one or more digestive enzymes and one or more medications used to treat attention deficit disorder;

forming a color blend by blending an intimate admixture of a plurality of pharmaceutically acceptable dyes and a silicified microcrystalline cellulose;

combining the active blend, the color blend and a disintegrant into a preblend;

adding a lubricant to the preblend to form a final blend; and

compressing the final blend to form the pharmaceutical preparation.

19. The method of claim 18, wherein the silicified microcrystalline cellulose is ProSolv SMCC.

20. The method of claim 18, wherein the silicified microcrystalline cellulose has a particle size of 40 to 90 micrometers.

21. The method of claim 18, wherein the disintegrant is selected from the group consisting of:

sodium starch glycolate, pregelatinized starch, cellulose, and a combination thereof.

22. The method of claim 22, wherein the lubricant is selected from a group consisting of:

magnesium stearate, calcium stearate, talc, stearic acid, and a combination thereof.