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|Title:||Oral dosage forms for oxygen-containing active agents and oxyl-containing polymer|
|Abstract:||The disclosed invention is drawn to pharmaceutical tablets that provide delivery of active agents having at least three oxygen-containing groups, as well as a second active ingredient. Non-limiting examples of three oxygen-containing group active agents include guaifenesin, codeine, hydrocodone, and their pharmaceutically acceptable salts. In one embodiment, a pharmaceutical tablet for oral administration once every 12 hours is provided. The tablet includes a first active agent that is a tri-oxy active agent, a second active agent, and a release rate controlling non-ionic oxyl-containing hydrophilic polymer. The total oxyl content of the hydrophilic polymer in the tablet is about 4.times.10.sup.-4 moles to about 2.0.times.10.sup.-3 moles.|
|Inventor(s):||Giliyar; Chandrashekar (Salt Lake City, UT), Nachaegari; Satish Kumar (Salt Lake City, UT), Nachiappan; Chidambaram (Sandy, UT), Patel; Mahesh V. (Salt Lake City, UT), Venkateshwaran; Srinivansan (Salt Lake City, UT)|
|Assignee:||Spriaso LLC (Salt Lake City, UT)|
1. A method of treatment, said method comprising: administering to an individual having cough or cold, twice a day, a pharmaceutical composition which is a solid
monolithic matrix tablet comprising 54 mg of codeine phosphate, 8 mg chlorpheniramine maleate or a pharmaceutically acceptable salt of chlorpheniramine and from 60 mg to 125 mg of a release rate controlling non-ionic oxyl-containing hydrophilic polymer.
2. The method of claim 1 wherein said release rate controlling non-ionic oxyl-containing hydrophilic polymer is hydroxypropyl methylcellulose.
3. The method of claim 2 wherein the ratio of total molar content of oxyl groups in the release rate controlling non-ionic oxyl-containing hydrophilic polymer to the total molar content of the oxygen groups in the codeine is about 2.5 to about 9.0.
4. The method of claim 1 wherein single dose administration of the pharmaceutical composition provides therapeutic levels of codeine, chlorpheniramine, or both, for about 12 hours.
5. The method of claim 1 wherein single dose administration of the pharmaceutical composition provides cough or cold symptom relief for about 12 hours.
6. The method of claim 1 wherein said pharmaceutical composition further comprises pseudoephedrine.
7. The method of claim 1 wherein said release rate controlling non-ionic oxyl-containing hydrophilic polymer is hydroxypropyl cellulose, methyl cellulose, carboxymethyl cellulose, hydroxypropyl methylcellulose, or a combination thereof.
8. The method of claim 1 wherein the release rate controlling non-ionic oxyl-containing hydrophilic polymer is hydroxypropyl methyl cellulose (HPMC) which has an average methoxy content of about 15 mole % to about 30 mole %.
9. The method of claim 1 wherein said pharmaceutical composition is resistant to alcohol extraction.
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