Method of treating attention deficit disorders with d-threo methylphenidate

Abstract

Methods for treating Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, AIDS Dementia Complex and cognitive decline in HIV-AIDS while minimizing drug hypersensitivity, toxicity, side effects, euphoric effect, and drug abuse potential by administration of d-threo-methylphenidate or pharmaceutically acceptable salts thereof.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a divisional application of Ser. No. 10 / 395,444, filed Mar. 24, 2003; which is a continuation of Ser. No. 09 / 864,617, filed May 24, 2001; which is a divisional application of application Ser. No. 09 / 337,310, filed Jun. 21, 1999 (now U.S. Pat. No. 6,255,325); which is a divisional of application Ser. No. 08 / 937,684, filed Sep. 29, 1997 (now U.S. Pat. No. 5,922,736); which is a continuation-in-part of application Ser. No. 08 / 827,230, filed Apr. 2, 1997 (now U.S. Pat. No. 5,908,850) and of application Serial. No. 08 / 647,642, filed May 15, 1996 (now abandoned); the former being a continuation of Ser. No. 08 / 567,131, filed Dec. 4, 1995, (now abandoned) and the latter being a continuation-in-part of application Ser. No. 08 / 583,317, filed Jan. 5, 1996, (now U.S. Pat. No. 5,733,756. The above are incorporated herein by reference in their entirety.FIELD OF THE INVENTION

[0002] The present invention relates to methods of treat...

Examples

example 1

[0032] Tablets for chewing, each containing 5 milligrams of d-threo-methylphenidate, can be prepared in the following manner:

Composition (for 1000 tablets)d-threo-methylphenidate5.00 gramsmannitol15.33 grams lactose10.00 grams talc1.40 gramsglycine0.83 gramsstearic acid0.66 gramssaccharin0.10 grams5% gelatin solution q.s.

[0033] All the solid ingredients are first forced through a sieve of 0.25 mm mesh width. The mannitol and the lactose are mixed, granulated with the addition of gelatin solution, forced through a sieve of 2 mm mesh width, dried at 50° C. and again forced through a sieve of 1.7 mm mesh width. The d-threo-methylphenidate, the glycine and the saccharin are carefully mixed, the mannitol, the lactose granulate, the stearic acid and the talc are added and the whole is mixed thoroughly and compressed to form tablets of approximately 10 mm diameter which are concave on both sides and have a breaking groove on the upper side.

example 2

[0034] Tablets, each containing 10 milligrams of d-threo-methylphenidate, can be prepared in the following manner:

Composition (for 1000 tablets)d-threo-methylphenidate10.0gramslactose328.5gramscorn starch17.5gramspolyethylene glycol 60005.0gramstalc25.0gramsmagnesium stearate4.0gramsdemineralized water q.s.

[0035] The solid ingredients are first forced through a sieve of 0.6 mm mesh width. Then the d-threo-methylphenidate, lactose, talc, magnesium stearate and half of the starch are intimately mixed. The other half of the starch is suspended in 65 milliliters of water and this suspension is added to a boiling solution of the polyethylene glycol in 260 milliliters of water. The resulting paste is added to the pulverulent substances, and the whole is mixed and granulated, if necessary with the addition of water. The granulate is dried overnight at 35° C., forced through a sieve of 1.2 mm mesh width and compressed to form tablets of approximately 10 mm diameter which are concave on bo...

example 3

[0037] The sodium lauryl sulfate is sieved into the d-threo-methylphenidate through a sieve of 0.2 mm mesh width and the two components are intimately mixed for 10 minutes. The microcrystalline cellulose is then added through a sieve of 0.9 mm mesh width and the whole is again intimately mixed for 10 minutes. Finally, the magnesium stearate is added through a sieve of 0.8 mm width and, after mixing for a further 3 minutes, the mixture is introduced in portions of 28 milligrams each into size 0 (elongated) gelatin dry-fill capsules.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a divisional application of Ser. No. 10 / 395,444, filed Mar. 24, 2003; which is a continuation of Ser. No. 09 / 864,617, filed May 24, 2001; which is a divisional application of application Ser. No. 09 / 337,310, filed Jun. 21, 1999 (now U.S. Pat. No. 6,255,325); which is a divisional of application Ser. No. 08 / 937,684, filed Sep. 29, 1997 (now U.S. Pat. No. 5,922,736); which is a continuation-in-part of application Ser. No. 08 / 827,230, filed Apr. 2, 1997 (now U.S. Pat. No. 5,908,850) and of application Serial. No. 08 / 647,642, filed May 15, 1996 (now abandoned); the former being a continuation of Ser. No. 08 / 567,131, filed Dec. 4, 1995, (now abandoned) and the latter being a continuation-in-part of application Ser. No. 08 / 583,317, filed Jan. 5, 1996, (now U.S. Pat. No. 5,733,756. The above are incorporated herein by reference in their entirety.FIELD OF THE INVENTION

[0002] The present invention relates to methods of treat...

Examples

example 1

[0032] Tablets for chewing, each containing 5 milligrams of d-threo-methylphenidate, can be prepared in the following manner:

Composition (for 1000 tablets)d-threo-methylphenidate5.00 gramsmannitol15.33 grams lactose10.00 grams talc1.40 gramsglycine0.83 gramsstearic acid0.66 gramssaccharin0.10 grams5% gelatin solution q.s.

[0033] All the solid ingredients are first forced through a sieve of 0.25 mm mesh width. The mannitol and the lactose are mixed, granulated with the addition of gelatin solution, forced through a sieve of 2 mm mesh width, dried at 50° C. and again forced through a sieve of 1.7 mm mesh width. The d-threo-methylphenidate, the glycine and the saccharin are carefully mixed, the mannitol, the lactose granulate, the stearic acid and the talc are added and the whole is mixed thoroughly and compressed to form tablets of approximately 10 mm diameter which are concave on both sides and have a breaking groove on the upper side.

example 2

[0034] Tablets, each containing 10 milligrams of d-threo-methylphenidate, can be prepared in the following manner:

Composition (for 1000 tablets)d-threo-methylphenidate10.0gramslactose328.5gramscorn starch17.5gramspolyethylene glycol 60005.0gramstalc25.0gramsmagnesium stearate4.0gramsdemineralized water q.s.

[0035] The solid ingredients are first forced through a sieve of 0.6 mm mesh width. Then the d-threo-methylphenidate, lactose, talc, magnesium stearate and half of the starch are intimately mixed. The other half of the starch is suspended in 65 milliliters of water and this suspension is added to a boiling solution of the polyethylene glycol in 260 milliliters of water. The resulting paste is added to the pulverulent substances, and the whole is mixed and granulated, if necessary with the addition of water. The granulate is dried overnight at 35° C., forced through a sieve of 1.2 mm mesh width and compressed to form tablets of approximately 10 mm diameter which are concave on bo...

example 3

[0037] The sodium lauryl sulfate is sieved into the d-threo-methylphenidate through a sieve of 0.2 mm mesh width and the two components are intimately mixed for 10 minutes. The microcrystalline cellulose is then added through a sieve of 0.9 mm mesh width and the whole is again intimately mixed for 10 minutes. Finally, the magnesium stearate is added through a sieve of 0.8 mm width and, after mixing for a further 3 minutes, the mixture is introduced in portions of 28 milligrams each into size 0 (elongated) gelatin dry-fill capsules.

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