Dosage forms with sustained release melatonin pellets

• Main Authors: HUSSEN, DIETER, SHAH SNEHAL M
• Format: Patent
• Language: Chinese; English
• Published: 12.08.2022
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

The present invention proposes a composition comprising a therapeutically effective oral pharmaceutical dosage form. The dosage form includes an aqueous carrier material having an acidic pH and a plurality of individual pellets having a first dose of melatonin therein. The individual pellets include (i) a solid core; (ii) an active coating over the solid core, the active coating comprising melatonin and a hydrophilic binder; and (iii) an enteric coating over the active coating. The dissolution pH of the enteric coating is higher than the acidic pH of the aqueous carrier material. 本发明提出了一种组合物，该组合物包括治疗有效的口服药物剂型。该剂型包括具有酸性pH的水性载体材料和在其中具有第一剂量的褪黑激素的多个单独的小丸。该单独的小丸包括(i)实芯；(ii)在该实芯上方的活性包衣，该活性包衣包括褪黑激素和亲水性粘结剂；和(iii)在该活性包衣上方的肠溶包衣。该肠溶包衣的溶解pH高于该水性载体材料的该酸性pH。