Adjei Akwete L.,Chen Sibao,Kupper Robert Joe,Mancinelli Vincent
申请号：
NZ62946813
公开号：
NZ629468A
申请日:
2013.03.01
申请国别(地区):
NZ
年份:
2017
代理人:
摘要：
Disclosed is an immediate release solid oral dosage form comprising a plurality of particles, each particle comprising: (i) a core comprising a first active agent (e.g., opioid analgesic, oxycodone hydrochloride)； (ii) a coating comprising a second active agent layered over the core； and (iii) a material that is sensitive to acidic pH (e.g., polyacrylate, a polysaccharide, an ion exchange resin) layered over the coated core； wherein the dosage form releases at least about 70% of the second active agent within 45 minutes as measured by in-vitro dissolution in a USP Apparatus 2 (paddle) at 50 rpm in 500 ml 0.1 N HCI at 37° C. The immediate release solid oral dosage forms are tamper resistant and have high viscosity when a unit dose of the dosage form is mixed with 0.5 to about 10 ml of distilled water. This reduces the ability of the drug (e.g., opioid agonist) from being drawn up into a syringe, or from being systemically absorbed, when administered by the parenteral or nasal route.
