Methods of preparing tamper resistant solid oral dosage forms
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-009/28
A61K-009/20
A61K-009/00
A61K-009/50
A61K-031/135
A61K-031/485
A61K-045/06
출원번호
US-0992789
(2016-01-11)
등록번호
US-9707180
(2017-07-18)
발명자
/ 주소
Sackler, Richard S.
출원인 / 주소
Purdue Pharma L.P.
대리인 / 주소
Lowenstein Sandler LLP
인용정보
피인용 횟수 :
0인용 특허 :
226
초록
Disclosed in certain embodiments is a solid oral dosage form comprising: (a) an inert tamper resistant core; and (b) a coating surrounding the core, the coating comprising an active agent.
대표청구항▼
1. A method of preparing a solid oral dosage form comprising: surrounding an inert tamper resistant core having a breaking strength of at least 400 Newtons with a coating comprising an opioid analgesic selected from the group consisting of morphine, codeine, oxycodone, hydrocodone, hydromorphone, ox
1. A method of preparing a solid oral dosage form comprising: surrounding an inert tamper resistant core having a breaking strength of at least 400 Newtons with a coating comprising an opioid analgesic selected from the group consisting of morphine, codeine, oxycodone, hydrocodone, hydromorphone, oxymorphone and pharmaceutically acceptable salts thereof, wherein the coating provides a controlled release of the opioid analgesic for a time of at least 12 hours,wherein the inert tamper resistant core comprises an inner component and an outer component coated on the inner component,wherein the inert tamper resistant core does not include the opioid analgesic, andwherein the solid oral dosage form is a tablet comprising a single coated core that comprises a therapeutically effective amount of the opioid analgesic. 2. A method of preparing a solid oral dosage form comprising: (a) preparing an inert tamper resistant core having a breaking strength of at least 400 Newtons, wherein the inert tamper resistant core comprises an inner component and an outer component coated on the inner component, and(b) surrounding the core with a coating comprising an opioid analgesic selected from the group consisting of morphine, codeine, oxycodone, hydrocodone, hydromorphone, oxymorphone and pharmaceutically acceptable salts thereof, wherein the coating provides a controlled release of the opioid analgesic for a time of at least 12 hours,wherein the inert tamper resistant core does not include the opioid analgesic,wherein the solid oral dosage form is a tablet comprising a single coated core that comprises a therapeutically effective amount of the opioid analgesic. 3. The method of claim 1, wherein the tamper resistant core comprises a gelling agent. 4. The method of claim 3, wherein the gelling agent is selected from the group consisting of sugar, sugar derived alcohols, mannitol, sorbitol, starch, microcrystalline cellulose, sodium carboxymethylcellulose, methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose, attapulgite, bentonite, dextrin, alginate, carrageenan, gum tragacanth, gum acacia, guar gum, xanthan gum, pectin, gelatin, kaolin, lecithin, magnesium aluminum silicate, carbomer, carbopol, polyvinylpyrrolidone, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, silicon dioxide, surfactant, mixed surfactant/wetting agent, emulsifier and mixtures thereof. 5. The method of claim 4, wherein the gelling agent is selected from the group consisting of sodium carboxymethylcellulose, methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, alginate, carrageenan, gum tragacanth, gum acacia, guar gum, xanthan gum, pectin, polyethylene oxide, polyvinyl alcohol and mixtures thereof. 6. The method of claim 5, wherein the gelling agent comprises alginate. 7. The method of claim 5, wherein the gelling agent comprises xanthan gum. 8. The method of claim 5, wherein the gelling agent comprises hydroxypropylmethylcellulose. 9. The method of claim 5, wherein the opioid analgesic comprises morphine sulfate or oxycodone hydrochloride. 10. A method of preparing a solid oral dosage form comprising: surrounding an inert tamper resistant core with a coating comprising an opioid analgesic selected from the group consisting of morphine, codeine, oxycodone, hydrocodone, hydromorphone, oxymorphone and pharmaceutically acceptable salts thereof, wherein the coating provides a controlled release of the opioid analgesic for a time of at least 12 hours,wherein the inert tamper resistant core comprises an inner component and an outer component coated on the inner component,wherein the inert tamper resistant core does not include the opioid analgesic; andwherein the inert tamper resistant core comprises a gelling agent comprising xanthan gum,wherein the solid oral dosage form is a tablet comprising a single coated core that comprises a therapeutically effective amount of the opioid analgesic. 11. The method of claim 10, wherein the gelling agent further comprises an agent selected from the group consisting of sugar, sugar derived alcohols, mannitol, sorbitol, starch, microcrystalline cellulose, sodium carboxymethylcellulose, methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose, attapulgite, bentonite, dextrin, alginate, carrageenan, gum tragacanth, gum acacia, guar gum, xanthan gum, pectin, gelatin, kaolin, lecithin, magnesium aluminum silicate, carbomer, carbopol, polyvinylpyrrolidone, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, silicon dioxide, surfactant, mixed surfactant/wetting agent, emulsifier and mixtures thereof. 12. The method of claim 11, wherein the gelling agent further comprises an agent selected from the group consisting of sodium carboxymethylcellulose, methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, alginate, carrageenan, gum tragacanth, gum acacia, guar gum, xanthan gum, pectin, polyethylene oxide, polyvinyl alcohol and mixtures thereof. 13. The method of claim 10, wherein the gelling agent further comprises alginate. 14. The method of claim 13, wherein the gelling agent further comprises hydroxypropylmethylcellulose. 15. The method of claim 10, wherein the active agent comprises morphine sulfate or oxycodone hydrochloride. 16. The method of claim 10, wherein the inert tamper resistant core has a breaking strength of at least 400 Newtons. 17. A method of preparing a solid oral dosage form comprising: (a) preparing an inert tamper resistant core wherein the inert tamper resistant core comprises an inner component and an outer component coated on the inner component and wherein the inert tamper resistant core comprises a gelling agent comprising a mixture comprising xanthan gum, hydroxypropylmethylcellulose and alginate, and(b) surrounding the core with a coating comprising an acrylic polymer and an opioid analgesic selected from the group consisting of morphine, codeine, oxycodone, hydrocodone, hydromorphone, oxymorphone and pharmaceutically acceptable salts thereof, wherein the coating provides a controlled release of the opioid analgesic for a time of at least 12 hours,wherein the inert tamper resistant core does not include the opioid analgesic,wherein the solid oral dosage form is a tablet comprising a single coated core that comprises a therapeutically effective amount of the opioid analgesic. 18. The method of claim 17, wherein the inert tamper resistant core has a breaking strength of at least 400 Newtons.
연구과제 타임라인
LOADING...
LOADING...
LOADING...
LOADING...
LOADING...
이 특허에 인용된 특허 (226)
Khanna Ish K. (Vernon Hills IL) Weier Richard M. (Lake Bluff IL) Collins Paul W. (Deerfield IL) Yu Yi (Skokie IL) Xu Xiangdong (Evanston IL) Partis Richard A. (Evanston IL) Koszyk Francis J. (Prospec, 1,2-aryl and heteroaryl substituted imidazolyl compounds for the treatment of inflammation.
Black Cameron (Pointe Claire CAX) Mancini Joseph A. (St. Leonard CAX) Lau Cheuk K. (Ile Bizard CAX) Prasit Petpiboon (Kirkland CAX) Vickers Philip J. (Pierrefonds CAX 4), 1-aroyl-3-indolyl alkanoic acids and derivatives thereof useful as anti-inflammatory agents.
Hirsh,Jane; Kibanov,Alexander M.; Swager,Timothy M.; Buchwald,Stephen L.; Lo,Whe Yong; Fleming,Alison B.; Rariy,Roman V., Abuse-deterrent pharmaceutical compositions of opiods and other drugs.
Black W. Cameron (Pointe-Claire CAX) Li Chun-Sing (Dollard Des Ormeaux CAX) Guay Daniel (Notre Dame de L\lle Perrot CAX) Prasit Petpiboon (Kirkland CAX) Roy Patrick (Dollard Des Ormeaux CAX), Alkanesulfonamido-1-indanone derivatives as inhibitors of cyclooxygenase.
Oshlack Benjamin (New York NY) Chasin Mark (Manalapan NJ) McGinity James (Austin TX) Bodmeier Roland (Austin TX), Aqueous dispersions of zein and preparation thereof.
Gauthier Jacques Y. (Laval CAX) Lau Cheuk K. (Ile Bizard CAX) LeBlanc Yves (Kirkland CAX) Li Chun-Sing (Dollard des Ormeaux CAX) Roy Patrick (Dollard des Ormeaux CAX) Therien Michel (Laval CAX) Wang , Aryl substituted 5,5 fused aromatic nitrogen compounds as anti-inflammatory agents.
Leshchiner Edward (Cresskill NJ) Balazs Endre A. (Fort Lee NJ) Larsen Nancy E. (Highland Mills NY) Leshchiner Adelva (Cresskill NJ), Biocompatible viscoelastic gel slurries, their preparation and use.
Kuczynski Anthony L. ; Childers Jerry D. ; Barclay Glen E. ; Rodriguez Susan ; Merrill Sonya, Composition and dosage form comprising opioid antagonist.
Blumberg Peter M. (Frederick MD), Composition of resiniferatoxin and analogues thereof to cause sensory afferent C-Fiber and thermoregulatory desensitizat.
Drust Eugene G. (Norwich NY) Kasting Gerald B. (Wyoming OH) Smith Ronald L. (West Chester OH) Szkutak Joan B. (West Chester OH), Compositions for the transdermal delivery of pharmaceutical actives.
Oshlack Benjamin (New York NY) McGinity James (Austin TX) Chasin Mark (Manalapan NJ) Bodmeier Roland (Austin TX), Controlled release coatings derived from aqueous dispersions of zein.
Goldie Robert S. (Cambridge GB2) Malkowska Sandra T. A. (Cambridge GB2) Leslie Stewart T. (Cambridge GB2) Miller Ronald B. (Basel CHX), Controlled release dihydrocodeine composition.
Oshlack Benjamin (New York NY) Chasin Mark (Manalapan NJ) Pedi ; Jr. Frank (Yorktown Heights NY), Controlled release formulations coated with aqueous dispersions of acrylic polymers.
Oshlack Benjamin (New York NY) Pedi ; Jr. Frank (Yorktown Heights NY) Chasin Mark (Manalapan NJ), Controlled release formulations coated with aqueous dispersions of acrylic polymers.
Thinnayam N. Krishnamurthy CA; Andrew Darke CA, Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations.
Goldie Robert S. (Comberton GB2) Malkowska Sandra T. A. (Landbeach GB2) Leslie Stewart T. (Cambridge GB2) Miller Ronald B. (Basel CHX), Controlled release hydromorphone composition.
Goldie Robert S. (Comberton GBX) Malkowska Sandra T. A. (Landbeach GBX) Leslie Stewart T. (Cambridge GBX) Miller Ronald B. (Basel CHX), Controlled release hydromorphone composition.
Oshlack Benjamin (New York NY) Chasin Mark (Manalpan NJ) Minogue John J. (Mount Vernon NY) Kaiko Robert F. (Weston CT), Controlled release oxycodone compositions.
Oshlack Benjamin (New York NY) Chasin Mark (Manalpan NJ) Minogue John J. (Mount Vernon NY) Kaiko Robert F. (Weston CT), Controlled release oxycodone compositions.
Oshlack Benjamin (New York NY) Chasin Mark (Manalpan NJ) Minogue John Joseph (Mount Vernon NY) Kaiko Robert Francis (Weston CT), Controlled release oxycodone compositions.
Oshlack Benjamin (New York NY) Chasin Mark (Manalpan NJ) Pedi ; Jr. Frank (Yorktown Heights NY), Controlled-release formulations coated with aqueous dispersions of ethylcellulose.
Prasit Petpiboon (Kirkland CAX) Guay Daniel (Iie Perrot CAX) Wang Zhaoyin (Pierrefonds CAX) Leger Serge (Dollar des Ormeaux CAX) Therien Michel (Laval CAX), Diaryl bicyclic heterocycles as inhibitors of cyclooxygenase-2.
Bjork, Anders K. K.; Olsson, Knut G.; Abramo, Aina L.; Christensson, Erik G., Diphenylbutyl-piperazinecarboxamides in pharmaceutical compositions and methods.
Sawada, Toyohiro; Sako, Kazuhiro; Yoshioka, Tatsunobu; Watanabe, Shunsuke, Drug delivery system for averting pharmacokinetic drug interaction and method thereof.
Han, Chien-Hsuan; Hou, Sui Yuen Eddie; Reid, Monica L., Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic.
Mayer, David J.; Price, Donald D.; Mao, Jianren; Lyle, John W., Inhibiting the development of tolerance to and/or dependence on a narcotic addictive substance.
Mayer David J. (Richmond VA) Price Donald D. (Richmond VA) Mao Jianren (Richmond VA) Lyle John W. (Belmar NJ), Inhibiting the development of tolerance to and/or dependence on an addictive substance.
Crain Stanley M. (Leonia NJ) Shen Ke-fei (Flushing NY), Method of simultaneously enhancing analgesic potency and attenuating dependence liability caused by morphine and other o.
Sackler Richard S. (Greenwich CT) Kaiko Robert F. (Weston CT) Goldenheim Paul (Wilton CT), Method of treating pain by administering 24 hour oral opioid formulations.
Sackler Richard (Greenwich CT) Goldenheim Paul (Wilton CT) Kaiko Robert (Weston CT), Method of treating pain by administering 24 hour oral opioid formulations exhibiting rapid rate of initial rise of plasm.
Kumar, Vijai; Dixon, David; Tewari, Divya; Wadgaonkar, Dilip B., Methods and compositions for deterring abuse of drugs susceptible to abuse and dosage forms thereof.
Colombo Paolo (Milan ITX) Cardona Antonio C. (Milan ITX) Pifferi Giorgio (Milan ITX), Multilayer matrix systems for the controlled release of active principles.
Lau Cheuk Kun (Ile Bizard CAX) Black Cameron (Pointe Claire CAX) Guay Daniel (Ile Perrot CAX) Gauthier Jacques-Yves (Laval CAX) LeBlanc Yves (Kirkland CAX) Roy Patrick (Dollard des Ormeaux CAX) Ducha, N-benzyl indol-3-yl butanoic acid derivatives as cyclooxygenase inhibitors.
Lau Cheuk K. (Ile Bizard CAX) Black Cameron (Pointe Claire CAX) Belley Michel (Pierrefonds CAX), N-benzyl-3-indoleacetic acids as antiinflammatory drugs.
Lau Cheuk K. (Ile Bizard CAX) Black Cameron (Pointe Claire CAX) Guay Daniel (Ile Perrot CAX) Gauthier Jacques Y. (Laval CAX) LeBlanc Yves (Kirkland CAX) Roy Patrick (Dollard des Ormeaux CAX) Ducharme, N-benzylindol-3-yl propanoic acid derivatives as cyclooxygenase inhibitors.
Houn Simon Hsia ; David Fan, Nutritive composition for cardiovascular health containing fish oil, garlic, rutin, capsaicin, selenium, vitamins and juice concentrates.
Shaw Irving F. (East Rockaway NY) Berk Jerome (New Rochelle NY), Orally administered drug composition for therapy in the treatment of narcotic drug addiction.
Wong Patrick S. L. (Hayward CA) Barclay Brian L. (Sunnyvale CA) Deters Joseph C. (Mt. View CA) Theeuwes Felix (Los Altos CA), Osmotic device for administering certain drugs.
Wong Patrick S. L. (Hayward CA) Barclay Brian (Sunnyvale CA) Deters Joseph C. (Mt. View CA) Theeuwes Felix (Los Altos CA), Osmotic device with dual thermodynamic activity.
Guillaumet Grald (Orleans FRX) Flouzat Christine (Clermont Ferrand FRX) Devissaguet Michelle (Neuilly sur Seine FRX) Renard Pierre (Versailles FRX) Caignard Daniel H. (Paris FRX) Adam Grard (le Mesni, Oxazolopyridine compounds, compositions and use.
Fukunaga Atsuo F. (5411 Littlebow Rd. Rancho Palos Verdes CA 90274) Funuknaga Alex S. (5411 Littlebow Rd. Rancho Palos Verdes CA 90274), Pharmaceutical compositions including mixtures of an adenosine compound and a catecholamine.
Batt Douglas G. (Wilmington DE) Pinto Donald J. P. (Newark DE) Orwat Michael J. (Wilmington DE) Petraitis Joseph J. (Glenmoore PA) Pitts William J. (Newark DE), Prostaglandin synthase inhibitors.
Oshlack Benjamin (New York NY) Chasin Mark (Manalapan NJ) Pedi ; Jr. Frank (Yorktown Heights NY), Stabilized controlled release formulations having acrylic polymer coating.
Oshlack Benjamin (New York NY) Chasin Mark (Manalapan NJ) Pedi ; Jr. Frank (Yorktown Heights NY), Stabilized controlled release substrate having a coating derived from an aqueous dispersion of hydrophobic polymer.
Oshlack Benjamin (New York NY) Pedi ; Jr. Frank (Yorktown Heights NY) Chasin Mark (Manalapan NJ), Stabilized controlled release substrate having a coating derived from an aqueous dispersion of hydrophobic polymer.
Heafield Joanne,GB2 ; Knott Trevor John,GB2 ; Leslie Stewart Thomas,GB2 ; Malkowska Sandra Therese Antoinette,GB2 ; Miller Ronald Brown,CHX ; Prater Derek Allan,GB2 ; Smith Kevin John,GB2, Sustained release compositions of morphine and a method of preparing pharmaceutical compositions.
Schor Joseph M. (Locust Valley NY) Nigalaye Ashok (Jackson Heights NY) Gaylord Norman G. (New Providence NJ), Sustained release therapeutic compositions based on high molecular weight hydroxypropylmethylcellulose.
Staniforth John N.,GB2 ; Sherwood Bob E. ; Hunter Edward A., Sustained-release formulations utilizing pharmaceutical excipient having improved compressibility.
Chien Yie W. (North Brunswick NJ) Chiang Chin-Chih (Piscataway NJ) Tojo Kabuji (Highland Park NJ), Transdermal absorption dosage unit for narcotic analgesics and antagonists and process for administration.
Gale Robert M. (Los Altos CA) Goetz Victor (Palo Alto CA) Lee Eun S. (Redwood City CA) Taskovich Lina T. (Palo Alto CA) Yum Su I. (Los Altos CA), Transdermal administration of fentanyl and device therefor.
Hille Thomas (Neuwied DEX) Deurer Lothar (Koblenz DEX) Hoffmann Hans-Rainer (Neuwied DEX), Transdermal therapeutic system comprising as active component buprenorphine.
※ AI-Helper는 부적절한 답변을 할 수 있습니다.