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US 5,688,518 AGranted
Antidepressive therapy
AssigneeAlza Corporation
InventorsAtul Devdatt Ayer, Dana Ridzon
Life of this patent
Estimating the term…
Abstract
A dosage form is provided for administering a drug of the formula ##STR1## to a patient to produce an anxiolytic benefit in the patient.
Claims30
A therapeutic composition of matter comprising:
- (a) less than 45% by weight of a drug of the following formula:
- ##STR9## in either exo or endo form and the base and pharmaceutically acceptable salts thereof;
- wherein A is selected from the group consisting of an oxygen atom, a methylene group and an ethylene group, the full line embracing a broken line (------) designates either a single bond or a double bond, R is a phenyl group optionally substituted with a member selected from the group consisting of halogen, an alkyl group of 1-4 carbon atoms, an alkoxy group of 1-4 carbon atoms, a trifluoromethyl group, a 2-pyridyl group and a 2-pyrimidinyl group;
- (b) 30% to 60% by weight of a polymeric composition comprising:
- (i) a first polymer selected from the group consisting of the repeating molecular unit --(--O--CH.sub.2 CH.sub.2 --)--.sub.n wherein n is in the range of 4000 to 5500, or a second polymer having the same repeating molecular unit wherein n is in the range of 5700 to 7500;
- and,
- (c)
- (ii) 0-3% by weight of a lubricant;
- (iii) 0-20% by weight of an osmagent;
- (iv) 0-4% by weight of an antioxidant and
- (v) 0-10% by weight of a binder.
8 more elements
The composition of any preceding claim wherein said composition contains from 1 to 750 mg of the drug.
An osmotic dosage form comprising:
- (a) the therapeutic composition of any preceding claim contained within a compartment formed at least in part by a semipermeable material;
- (b) a passageway providing communication between said composition and the exterior of said compartment;
- (c) a push composition is said compartment which swells when said semipermeable material is contacted by water to push said therapeutic composition through said passageway at a substantially constant rate over a period of up to 30 hours.
A therapeutic composition of matter comprising:
- (a) tandospirone citrate;
- (b) a polymeric composition comprising:
- (i) a polymer selected from the group consisting of the repeating molecular unit --(--O--CH.sub.2 CH.sub.2 --)--.sub.n wherein n is in the range of 4000 to 5500, and a polymer having the same repeating molecular unit wherein n is in the range of 5700 to 7500;
- and,
- (c)
- (ii) 0-3% by weight of a lubricant;
- (iii) 0-20% by weight of an osmagent;
- (iv) 0-4% by weight of an antioxidant and
- (v) 0-10% by weight of polyvinyl a binder.
6 more elements
A dosage form comprising 1 mg to 750 mg of a tandospirone salt that is released at a continuous rate of 1 mg/hr to 20 mg/hr by the dosage form.
A process for preparing a drug-free push formulation for use in an osmotic dosage form, said formulation comprising:
- (a) 50%-75% by weight of a polymer consisting of the repeating molecular unit --(--O--CH.sub.2 CH.sub.2 --)--.sub.n wherein n is in the range of 90,000 to 230,000;
- (b) 15%-35% by weight of an osmagent;
- (c) 0.1%-20% by weight of a cellulose ether;
- (d) 0%-5% of a lubricant;
- (e) 0%-10% by weight of an inert pigment;
- and
- (f) 0.03%-4% by weight of butyl hydroxytoluene;
- said process comprising the steps of:
- (1) thoroughly mixing components (a), (b), (e) and a portion of (c) in an air suspended fluid bed;
- (2) forming an aqueous solution of the remainder of component (c);
- (3) forming an ethanolic solution of component (e);
- (4) thoroughly mixing the aqueous and ethanolic solutions to form a coating solution;
- (5) spraying said coating solution into the fluid bed to coat the suspended solids;
- (6) drying the coated particulate product so produced to a moisture content no greater than 0.29%;
- and
- (7) mixing component (d) into the coated particulate product.
13 more elements
Dependencies are inferred from the claim text.