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US 12,514,818 B2Granted
Pharmaceutical compositions comprising a floating interpenetrating polymer network forming system
AssigneeTris Pharma, Inc.
InventorsParas Rameshlal Jain, Sachin Vasant Chaudhari
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Abstract
Drug delivery systems comprising a floating interpenetrating network (IPN) are provided. The pharmaceutical compositions contain at least one IPN forming system, at least one drug, and at least one gas generating agent, such that upon oral ingestion of the compositions, a floating IPN is formed in situ. These floating IPN provide extended release of the drug entrapped therein for at least about 3 hours.
Claims17
An orally administrable extended release composition which comprises a floating inter-penetrating network (IPN) forming system comprising:
- (a) at least one drug in a drug-ion exchange resin complex;
- (b) an inter-penetrating network (IPN) forming blend, which comprises:
- (i) at least two IPN forming polymers comprising at least one IPN forming anionic polymer and at least a second, different, IPN forming anionic polymer or at least one IPN forming galactomannan, wherein there are no covalent bonds between the at least two IPN forming polymers;
- (ii) at least one cross-linking agent which interacts with the at least one IPN forming anionic polymer and at least one cross-linking agent which interacts with the second IPN forming anionic polymer or IPN forming galactomannan (i) to form an IPN;
- and
- (iii) at least one non-toxic gas generating agent, wherein the gas generating agent forms a non-toxic gas when exposed to stomach acid,
- wherein following oral ingestion, the composition self-assembles into a floating IPN in situ, which comprises the drug-ion exchange resin complex and the non-toxic gas entrapped therein, thereby providing a floating IPN which further comprises the IPN-forming polymers individually cross-linked to cross-linking agent(s),
- further wherein the at least two IPN-forming polymers are not cross-linked to each other,
- provided that the composition does not include a gamma hydroxybutyrate and its salts, hydrates, tautomers, or solvates, or complexes thereof.
6 more elements
An orally administrable drug composition comprising a floating inter-penetrating network (IPN) forming system comprising:
- (a) at least one drug in a drug-ion exchange resin complex;
- (b) an inter-penetrating network (IPN) forming blend, which comprises:
- (i) at least two IPN forming polymers comprising at least one IPN forming anionic polymer and at least a second, different, IPN forming anionic polymer or at least one IPN forming galactomannan, wherein there are no covalent bonds between the at least two IPN forming polymers;
- (ii) at least one cross-linking agent which interacts with the at least one IPN forming anionic polymer and at least one cross-linking agent which interacts with the second IPN forming anionic polymer or IPN forming galactomannan (i) to form an IPN;
- and
- (iii) a non-toxic gas generating agent, wherein the gas generating agent forms a non-toxic gas when exposed to stomach acid,
- wherein following oral ingestion, the composition self-assembles into a floating IPN in situ, which comprises the drug-ion exchange resin complex and the non-toxic gas entrapped therein, thereby providing a floating IPN which further comprises the IPN-forming polymers individually cross-linked to the cross-linking agent(s),
- wherein the IPN forming blend comprises at least one anionic polymer selected from sodium alginate, carrageenan I, pectin, gellan gum, alginic acid, carrageenan k, sodium carboxymethylcellulose, xanthan gum, or combinations thereof and at least a second polymer which are at least partially crosslinked with a crosslinking agent,
- further wherein the at least two IPN-forming polymers are not cross-linked to each other,
- provided that the composition does not include a gamma hydroxybutyrate and its salts, hydrates, tautomers, or solvates, or complexes thereof.
7 more elements
A product comprising a reconstituted orally administrable extended release powder composition which comprises a floating inter-penetrating network (IPN) forming system comprising:
- (a) at least one drug in a drug-ion exchange resin complex;
- (b) an IPN forming powder blend, which comprises:
- (i) at least two IPN forming polymers comprising at least one IPN forming anionic polymer and at least a second, different, IPN forming anionic polymer or at least one IPN forming galactomannan, wherein there are no covalent bonds between the at least two IPN forming polymers;
- (ii) at least one cross-linking agent which interacts with the at least one IPN forming anionic polymer and at least one cross-linking agent which interacts with the second IPN forming anionic polymer or IPN forming galactomannan;
- and
- (iii) a non-toxic gas generating agent, wherein the gas generating agent forms a non-toxic gas when exposed to stomach acid,
- wherein following oral ingestion, the composition self-assembles into a floating IPN in situ, which comprises the drug-ion exchange resin complex and the non-toxic gas entrapped therein, thereby providing a floating IPN comprising the IPN-forming polymers individually cross-linked to the cross-linking agent(s),
- further wherein the at least two IPN-forming polymers are not cross-linked to each other,
- provided that the composition does not include a gamma hydroxybutyrate and its salts, hydrates, tautomers, or solvates, or complexes thereof;
- and
- (c) water,
- wherein the ratio, by weight, of the composition to water is 1:0.1 to 1:15, or 1:0.5 to 1:10, or 1:2 to 1:7.
9 more elements
An orally administrable extended release drug composition, which comprises a floating inter-penetrating network (IPN) forming system comprising:
- (a) at least one drug in a drug-ion exchange resin complex;
- (b) an inter-penetrating network (IPN) forming blend, which comprises:
- (i) at least two IPN forming polymers comprising at least one IPN forming anionic polymer and at least a second, different, IPN forming anionic polymer or at least one IPN forming galactomannan, wherein there are no covalent bonds between the at least two IPN forming polymers;
- (ii) at least one cross-linking agent which interacts with the at least one IPN forming anionic polymer and at least one cross-linking agent which interacts with the second IPN forming anionic polymer or IPN forming galactomannan (i) to form an IPN;
- and
- (iii) at least one non-toxic gas generating agent, wherein the gas generating agent forms a non-toxic gas when exposed to stomach acid,
- wherein the at least one IPN forming anionic polymer is gellan gum, and wherein the at least second, different, IPN forming anionic polymer, is carrageenan and/or xanthan gum;
- or the at least one IPN forming galactomannan is fenugreek gum or guar gum, wherein following oral ingestion, the composition self-assembles into a floating IPN in situ, which comprises the drug-ion exchange resin complex and the non-toxic gas entrapped therein, thereby providing a floating IPN which further comprises the IPN-forming polymers individually cross-linked to cross-linking agent(s),
- further wherein the at least one cross-linking agent which interacts with the at least one IPN forming anionic polymer is calcium carbonate or calcium chloride, and further wherein the at least one cross-linking agent which interacts with the second IPN forming anionic polymer or IPN forming galactomannan is calcium carbonate or calcium chloride,
- provided that the composition does not include a gamma hydroxybutyrate, its salts, hydrates, tautomers, or solvates, or complexes thereof.
7 more elements
Dependencies are inferred from the claim text.