التفاصيل البيبلوغرافية
| العنوان: |
SUSTAINED-RELEASE PREPARATIONS AND METHOD FOR PRODUCING THE SAME |
| Document Number: |
20090137684 |
| تاريخ النشر: |
May 28, 2009 |
| Appl. No: |
12/358426 |
| Application Filed: |
January 23, 2009 |
| مستخلص: |
The present invention relates to sustained-release preparations prepared by double granulation and methods for producing the same. The sustained-release preparations according to the present invention enables maintenance of effective blood concentration of drug for many hours via sustained release of the drug over 12 hours or more, and further its production is easy owing to convenience of process. |
| Inventors: |
PARK, Jin Woo (Seoul, KR); Bae, Joon Ho (Seoul, KR); Kim, Jung Ju (Yongin-si, KR) |
| Claim: |
1-13. (canceled) |
| Claim: |
14. A method for preparing sustained-release preparations comprising, obtaining primary granules by melt granulation of a drug using hydrophobic release-delaying additives; and obtaining secondary granules by wet granulation of the primary granules using hydrophobic wet-granulating materials. |
| Claim: |
15. The method of claim 14, wherein the preparations comprise 0.5 to 80% by weight of the drug, 10 to 65% by weight of the hydrophobic release-delaying additive, and 1 to 35% by weight of hydrophobic wet-granulation material. |
| Claim: |
16. The method of claim 14, wherein the drug is tramadol, morphine, hydromorphone, oxycodone, diamorphone, alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, benzitramide, buprenorphine, butorphanol, clonitazine, codeine, cyclazocin, desmorphine, dextromoramide, dezocine, dihydrocodeine, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiabutente, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, levorphanol, methadone, meperidine, heroine or pharmaceutically acceptable salts thereof. |
| Claim: |
17. The method of claim 14, wherein the hydrophobic release-delaying additives are one or more ingredients selected from a group consisting of natural or synthetic waxes, fatty acids, fatty alcohols, fatty acid esters, fatty acid glycerides including mono-, di- and tri-glyceride, hydrocarbons, hydrogenated fats, hydrogenated castor oils and hydrogenated vegetable oils. |
| Claim: |
18. The method of claim 17, wherein the fatty alcohols are one or more ingredients selected from a group consisting of cetostearyl alcohol, stearyl alcohol, myristyl alcohol and lauryl alcohol, and the fatty acid ester are one or more ingredients selected from a group consisting of glyceryl monostearate, glycerol monooleate, acetylated monoglyceride, tristearin, tripalmitin, cetyl ester wax, glyceryl palmitostearate and glyceryl behenate, and the waxes are one or more ingredients selected from a group consisting of beeswax, carnauba wax, glycol wax and castor wax. |
| Claim: |
19. The method of claim 14, wherein the hydrophobic wet-granulating materials are one or more ingredients selected from a group consisting of fatty alcohols, fatty acids, fatty acid esters, fatty acid glycerides, hydrocarbons, waxes, hydrogenated fats, hydrogenated castor oils, hydrogenated vegetable oils, allyl cellulose and acrylic polymer. |
| Claim: |
20. The method of claim 14, wherein the preparations further comprise pharmaceutical additives such as diluents, binders and lubricants. |
| Current U.S. Class: |
514/646 |
| Current International Class: |
61 |
| رقم الانضمام: |
edspap.20090137684 |
| قاعدة البيانات: |
USPTO Patent Applications |