Hydrogel-driven drug dosage form

Title: Hydrogel-driven drug dosage form

Related Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Preparations Characterized By Special Physical Form, Tablets, Lozenges, Or Pills, Sustained Or Differential Release Type, Layered Unitary Dosage Forms

Brief Patent Description - Full Patent Description - Patent Claims

The Patent Description & Claims data below is from USPTO Patent Application 20070087057, Hydrogel-driven drug dosage form.

1-131. (canceled)

132. A controlled release dosage form comprising a core and a coating around said core wherein: (a) said core comprises a drug-containing composition and a water-swellable composition, each occupying separate regions within said core; (b) said drug-containing composition comprises a low-solubility drug having a minimum aqueous solubility up to 1 to 2 mg/mL at a pH of 1-8 and a drug-entraining agent, wherein said drug entraining agent is PEO having a molecular weight of at least one of: (i) 500,000 to 800,000 daltons when the weight fraction of said low-solubility drug and said drug-entraining agents is less than about 80% of said drug-containing composition, wherein there is an inverse relationship between the preferred PEO molecular weight and the weight fraction of the drug-containing composition that is said low-solubility drug and said drug-entraining agent; and (ii) 100,000 to 300,000 when the weight fraction of said low-solubility drug and said drug-entraining agents is about 80% or more of said drug-containing composition; wherein the PEO molecular weight may vary higher or lower relative to the above values of molecular weight by 20% to 50%; and (c) said coating is water-permeable, water-insoluble, and has at least one delivery port therethrough, said coating comprising cellulose acetate (CA) and polyethylene glycol (PEG) having a weight ratio of CA:PEG of from about 6.5:3.5 to about 9:1; and wherein said drug-containing composition further comprises a concentration-enhancing polymer selected from hydroxypropylmethyl cellulose acetate succinate (HPMCAS), hydroxypropylmethyl cellulose (HPMC), hydroxy propylmethyl cellulose phthalate (HPMCP), cellulose acetate phthalate (CAP) cellulose acetate trimellitate (CAT), and polyvinylpyrrolidone (PVP); and said drug is not in the form of a solid dispersion.

133. A dosage form according to claim 132 wherein said drug-containing composition further comprises an ionic swelling agent selected from sodium croscarmellose and sodium starch glycolate.

134. A dosage form according to claim 132 wherein said drug containing composition further comprises a solubilizer.

135. A dosage form according to claim 133 wherein said drug containing composition further comprises a solubilizer.

136. A dosage form according to claim 134 or 135 wherein said solubilizer is an organic acid, and said drug has enhanced solubility in the presence of said organic acid.

137. A dosage form according to any one of claims 132 to 135 wherein said drug-containing composition further comprises a fluidizing agent.

138. A dosage form according to claim 137 wherein said fluidizing agent is selected from an organic acid and a sugar.

139. A dosage form according to claim 132 wherein said water-swellable composition has a swelling ratio of at least 3.5.

140. A dosage form according to claim 132 wherein said coating has a water flux (40/75) of at least 1.0.times.10.sup.-3 gm/cm.sup.2.hr.

141. A dosage form according to claim 132 wherein said coating is porous with a dry-state density of less than 0.9 times that of the same coating material in nonporous form.

142. A dosage form according to claim 132 wherein, following introduction of said dosage form to a use environment, at least about 70 wt % of said drug is released to said use environment within about 12 hours.

143. A controlled release dosage form according to claim 132 wherein said drug is an anti-impotence agent.

144. A controlled release dosage form according to claim 143 wherein said anti-impotence agent is sildenafil citrate.

Brief Patent Description - Full Patent Description - Patent Claims

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Industry Class:
Drug, bio-affecting and body treating compositions

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