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1. WO2022095203 - NALTREXONE AND RISPERIDONE COMBINATION SUSTAINED-RELEASE COMPOSITION

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Publication Number WO/2022/095203
Publication Date 12.05.2022
International Application No. PCT/CN2020/135369
International Filing Date 10.12.2020
IPC
A61K 9/16 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
16Agglomerates; Granulates; Microbeadlets
A61K 31/519 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
495having six-membered rings with two nitrogen atoms as the only ring hetero atoms, e.g. piperazine
505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
519ortho- or peri-condensed with heterocyclic rings
A61K 31/485 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
435having six-membered rings with one nitrogen as the only ring hetero atom
47Quinolines; Isoquinolines
485Morphinan derivatives, e.g. morphine, codeine
A61K 47/34 2017.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 47/32 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers
A61P 25/36 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
25Drugs for disorders of the nervous system
30for treating abuse or dependence
36Opioid-abuse
Applicants
  • 深圳善康医疗健康产业有限公司 SHENZHEN SCIENCARE MEDICAL INDUSTRIES CO., LTD [CN]/[CN]
Inventors
  • 颜携国 YAN, Xieguo
  • 严福乔 YAN, Fuqiao
  • 刘国辉 LIU, Guohui
  • 王实强 WANG, Shiqiang
Agents
  • 北京精金石知识产权代理有限公司 JJS INTELLECTUAL PROPERTY AGENCY LTD.
Priority Data
202011243436.509.11.2020CN
Publication Language Chinese (zh)
Filing Language Chinese (ZH)
Designated States
Title
(EN) NALTREXONE AND RISPERIDONE COMBINATION SUSTAINED-RELEASE COMPOSITION
(FR) COMPOSITION À LIBÉRATION PROLONGÉE DE COMBINAISON DE NALTREXONE ET DE RISPÉRIDONE
(ZH) 一种纳曲酮和利培酮复方缓释组合物
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Abstract
(EN) The present invention relates to a preparation method for a formulation, in particular, to a naltrexone and risperidone combination sustained-release composition, and a preparation method therefor and an application thereof. The naltrexone and risperidone combination sustained-release composition and the formulation thereof provided in the present invention can be sustained-released in vitro for more than 12 weeks, the release conforms to an approximate zero-order mode, and the release rate is stable; in the present invention, a suitable preparation method and parameter control are used, so that the release rates of naltrexone sustained-release microspheres and risperidone sustained-release microspheres in the body can be synchronized, and the administration period can be more conveniently controlled; further, the product provided by the present invention has a good effect in methamphetamine addiction tests, and can be used for preparing products for treating methamphetamine addiction.
(FR) La présente invention se rapporte à un procédé de préparation d'une formulation, en particulier, d'une composition à libération prolongée d'une combinaison de naltrexone et de rispéridone, et son procédé de préparation et son application. La composition à libération prolongée d'une combinaison de naltrexone et de rispéridone et sa formulation fournie dans la présente invention peuvent être libérées de manière prolongée in vitro pendant plus de 12 semaines, la libération est conforme à un mode d'ordre zéro approximatif, et la vitesse de libération est stable; dans la présente invention, un procédé de préparation approprié et une commande de paramètre sont utilisés, de telle sorte que les taux de libération de microsphères à libération prolongée de naltrexone et de microsphères à libération prolongée de rispéridone dans le corps peuvent être synchronisés, et la période d'administration peut être contrôlée de manière plus commode; en outre, le produit fourni par la présente invention a un bon effet dans des tests de dépendance à la méthamphétamine, et peut être utilisé pour préparer des produits pour traiter la dépendance à la méthamphétamine.
(ZH) 本发明涉及制剂的制备方法，具体涉及一种纳曲酮和利培酮复方缓释组合物及其制备方法和应用。本发明提供的纳曲酮和利培酮复方缓释组合物及其制剂，可在体外缓释达12周以上，释放符合近似零级模式，释放速率稳定；本发明采用合适的制备方法以及参数控制，使纳曲酮缓释微球和利培酮缓释微球在体内的释放率达到同步，更便于把控给药周期；进一步地，本发明提供的产品在甲基苯丙胺成瘾性试验中取得了较好的效果，可以用于制备治疗甲基苯丙胺成瘾的产品中。
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