摘要:
A sustained release dosage form is provided comprising a pharmaceutically active agent and pharmaceutically acceptable salts thereof and adapted to release as an erodible solid over a prolonged period of time, wherein the dosage form provides burst release of the pharmaceutically active agent without the use of an immediate release drug coating. The dosage form is able to deliver high doses of poorly soluble or slowly dissolving active agents at a controlled rate. Methods of using the dosage forms to treat disease or conditions in human patients are also disclosed.
摘要:
Sustained release dosage forms for twice daily oral dosing to a human patient for providing relief from pain are provided. The sustained release dosage form comprises an immediate release component and a sustained release component, wherein the immediate release component and the sustained release component collectively contain a therapeutically effective amount of an opioid analgesic and a therapeutically effective amount of nonopioid analgesic. In a preferred embodiment, the nonopioid analgesic is acetaminophen and the opioid analgesic is hydrocodone and pharmaceutically acceptable salts thereof, and in preferred embodiments, the pharmaceutically acceptable salt is bitartrate. The dosage forms produce plasma profiles in a patient characterized by a Cmax for hydrocodone of between about 0.6 ng/mL/mg to about 1.4 ng/mL/mg and an AUC for hydrocodone of between about 9.1 ng*hr/mL/mg to about 19.9 ng*hr/mL/mg (per mg hydrocodone bitartrate administered) and a Cmax for acetaminophen of between about 2.8 ng/mL/mg and 7.9 ng/mL/mg and an AUC for acetaminophen of between about 28.6 ng*hr/mL/mg and about 59.1 ng*hr/mL/mg (per mg acetaminophen administered) after a single dose.
摘要翻译:提供了持续释放剂型,每天两次口服给予患者以缓解疼痛。 持续释放剂型包括速释组分和持续释放组分,其中速释组分和持续释放组分共同含有治疗有效量的阿片样镇痛剂和治疗有效量的非阿片类止痛剂。 在优选的实施方案中,非阿片类镇痛剂是对乙酰氨基酚,阿片类镇痛剂是氢可酮及其药学上可接受的盐,并且在优选的实施方案中,药学上可接受的盐是酒石酸氢盐。 剂型在患者中产生血浆曲线,其特征在于氢可酮的C max为约0.6ng / mL / mg至约1.4ng / mL / mg,氢可酮的AUC为约9.1ng * hr / mL / mg至约 19.9ng * hr / mL / mg(每毫克给予的氢可酮酮可乐酮),对乙酰氨基酚的C max为约2.8ng / mL / mg至7.9ng / mL / mg,对乙酰氨基酚的AUC为约28.6ng * hr / mL / mg和约59.1ng * hr / mL / mg(施用每mg对乙酰氨基酚)。
摘要:
Sustained release dosage forms for twice daily oral dosing to a human patient for providing relief from pain are provided. The sustained release dosage form comprises an immediate release component and a sustained release component, wherein the immediate release component and the sustained release component collectively contain a therapeutically effective amount of an opioid analgesic and a therapeutically effective amount of nonopioid analgesic. In a preferred embodiment, the nonopioid analgesic is acetaminophen and the opioid analgesic is hydrocodone and pharmaceutically acceptable salts thereof, and in preferred embodiments, the pharmaceutically acceptable salt is bitartrate. The dosage forms produce plasma profiles in a patient characterized by a Cmax for hydrocodone of between about 0.6 ng/mL/mg to about 1.4 ng/mL/mg and an AUC for hydrocodone of between about 9.1 ng*hr/mL/mg to about 19.9 ng*hr/mL/mg (per mg hydrocodone bitartrate administered) and a Cmax for acetaminophen of between about 2.8 ng/mL/mg and 7.9 ng/mL/mg and an AUC for acetaminophen of between about 28.6 ng*hr/mL/mg and about 59.1 ng*hr/mL/mg (per mg acetaminophen administered) after a single dose.
摘要翻译:提供了持续释放剂型,每天两次口服给予患者以缓解疼痛。 持续释放剂型包括速释组分和持续释放组分,其中速释组分和持续释放组分共同含有治疗有效量的阿片样镇痛剂和治疗有效量的非阿片类止痛剂。 在优选的实施方案中,非阿片类镇痛剂是对乙酰氨基酚,阿片类镇痛剂是氢可酮及其药学上可接受的盐,并且在优选的实施方案中,药学上可接受的盐是酒石酸氢盐。 剂型在患者中产生血浆曲线,其特征在于氢可酮的C max为约0.6ng / mL / mg至约1.4ng / mL / mg,氢可酮的AUC为约9.1ng * hr / mL / mg至约 19.9ng * hr / mL / mg(每毫克给予的氢可酮酮可乐酮),对乙酰氨基酚的C max为约2.8ng / mL / mg至7.9ng / mL / mg,对乙酰氨基酚的AUC为约28.6ng * hr / mL / mg和约59.1ng * hr / mL / mg(施用每mg对乙酰氨基酚)。
摘要:
Methods and devices for maintaining a desired therapeutic drug effect over a prolonged therapy period are provided. In particular, oral dosage forms that release drug within the gastrointestinal tract at an ascending release rate over an extended time period are provided. The dosage forms may additionally comprise an immediate-release dose of drug.
摘要:
Methods and devices for maintaining a desired therapeutic drug effect over a prolonged therapy period are provided. In particular, oral dosage forms that release drug within the gastrointestinal tract at an ascending release rate over an extended time period are provided. The dosage forms may additionally comprise an immediate-release dose of drug.
摘要:
Methods and devices for maintaining a desired therapeutic drug effect over a prolonged therapy period are provided. In particular, oral dosage forms that release drug within the gastrointestinal tract at an ascending release rate over an extended time period are provided. The dosage forms may additionally comprise an immediate-release dose of drug.
摘要:
Compositions, systems and methods for administration of small volume sufentanil drug dosage forms via the oral transmucosal route of a subject for treatment of pain.
摘要:
Compositions, systems and methods for administration of small volume sufentanil drug dosage forms via the oral transmucosal route of a subject for treatment of pain.
摘要:
A method and apparatus are provided for designing educational assessments. In one embodiment, a method for guiding a user in the design of an assessment includes receiving, from the user, one or more goals relating to the assessment and translating those goals into a task specification for an assessment task in accordance with one or more user-defined variables.