Polymer compositions
The invention relates to novel a high-volume swelling hydrogel which comprises a plurality of pores which are defined by an interpenetrating network, and/or a semi-interpenetrating network and/or simple cross-linked arrangement of a plurality of one or more species of hydrophilic polymers, optionally together with one or more biocompatible polymers and optionally together with one or more plasticising agents, characterised in that at least some of the pores are at least partially collapsed and/or flattened, and further characterised in that the interpenetrating network and/or semi-interpenetrating network and/or cross-linked arrangement which defines the collapsed and/or flattened pores is substantially unbroken. The invention also relates to a process for preparing such hydrogels, and to their use as an appetite suppressant.
1 . A dosage regimen comprising the step of administering to a patient, suffering from being overweight, having obesity, having diabetes, or a combination thereof, wherein the dosage regimen comprises:
a first dose of a product formulation, which is retained in the stomach of the treated patient for at least one day;
wherein the product formulation comprises:
one or more compressed superporous hydrogels comprising a plurality of pores which are defined by a network structure formed by one or more hydrophilic polymers arranged in the form of one or more selected from an interpenetrating network, a semi-interpenetrating network and a simple cross-linked arrangement,
wherein at least some of the plurality of pores are collapsed and wherein the network structure which defines the collapsed pores is at least 50% unbroken,
wherein one or more of the hydrophilic polymers are made by the polymerisation and/or copolymerisation of one or more monomers selected from the group consisting of C1-C6-alkenyl amides and C1-C6-alkenyl acids, and
wherein the one or more compressed superporous hydrogels will swell to a diameter of ≥25 mm within 10 to 30 minutes of ingestion by the patient;
wherein the first dose comprises the one or more compressed superporous hydrogels in an amount which will swell to fill up to 80% of the volume of the treated patient's stomach.
2 . The dosage regimen according to claim 1 further comprising administering to the patient a second dose of the product formulation, which is retained in the stomach of the treated patient for at least one day, the second dose comprising one or more compressed superporous hydrogels in an amount which will swell to maintain up to 80% of the volume of the treated patient's stomach to be filled.
3 . The dosage regimen according to claim 2 further comprising administering one or more further doses of the product formulation, at time intervals of at least 12 hours, which are retained in the stomach of the treated patient for at least one day, the one or more further doses comprising one or more compressed superporous hydrogels.
4 . The dosage regimen according to claim 1 further comprising a step of administering the treated patient with at least 100 ml of water during and after ingestion of the first dose.
5 . The dosage regimen according to claim 4 further comprising a step of administering the treated patient with at least 300 kcal of foodstuffs during and after ingestion of the first dose.
6 . The dosage regimen according to claim 1 wherein the product formulation is retained within the treated patient's stomach for up to 7 days.
7 . The dosage regimen according to claim 1 wherein the product formulation is retained within the treated patient's stomach for up to 30 weeks.
8 . The dosage regimen according to claim 1 wherein the product formulation further comprises one or more non-superporous hydrogels.
9 . The dosage regimen according to claim 1 wherein the product formulation further comprises one or more superporous hydrogels that have not been treated with a compressive force.
10 . The dosage regimen according to claim 1 wherein the first dose of the product formulation is administered in an amount which will swell upon ingestion to fill up to 60% of the volume of the treated patient's stomach.
11 . The dosage regimen according to claim 1 wherein the first dose of the product formulation is administered in an amount which will swell upon ingestion to fill up to 50% of the volume of the treated patient's stomach.
12 . The dosage regimen according to claim 2 wherein the second dose of the product formulation is administered in an amount which will swell upon ingestion to maintain up to 60% of the volume of the treated patient's stomach to be filled.
13 . The dosage regimen according to claim 3 wherein the time intervals are at least 24 hours.
14 . The dosage regimen according to claim 3 wherein the time intervals are at least 48 hours.
15 . The dosage regimen according to claim 1 wherein the one or more compressed superporous hydrogels swell to a diameter >30 mm within 10 minutes of ingestion.
16 . The dosage regimen according to claim 1 wherein the one or more hydrophilic polymers further comprise one or more selected from methylcellulose, ethylcellulose, n-propylcellulose, hydroxyethylcellulose, hydroxy-n-propylcellulose, hydroxy-n-butylcellulose, hydroxypropylmethylcellulose, ethylhydroxyethylcellulose, carboxymethylcellulose, carboxymethylstarch, chitosan, alginate, gelatin, cationic dextran, dimethyl aminodextran, diethyl aminodextran, cationic dextrin, polyetherimide, heparin, hyaluronic acid, chondroitin, chondroitin sulfate, heparan sulfate, polygalacturonic acid, polyanuronic acid, polygalacturonic acid polyarabinic acid and polylysine.
17 . The dosage regimen according to claim 2 wherein the one or more hydrophilic polymers comprise alginate and the product of the polymerisation and/or copolymerisation of acrylamide.
18 . The dosage regimen according to claim 1 wherein the one or more compressed superporous hydrogels are produced by a process comprising a freeze-drying process.