Methods of reducing alcohol-induced dose dumping for opioid sustained release oral dosage forms
A technology of opioids and sustained-release agents, applied in the field of opioids, can solve problems such as respiratory depression, death, and overdose of opioid drugs
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Embodiment 1
[0302] Hydromorphone Tablets, Dual Layer 16mg System
[0303]Sustained release dosage forms of hydromorphone of the present invention suitable for, designed and shaped as osmotic drug delivery devices are prepared as follows: first prepare the pharmaceutical composition. 8.98 kg of hydromorphone hydrochloride, 2.2 kg of crospovidone (polyvinylpyrrolidone) identified as K29-32 and 67.06 kg of polyethylene oxide having an average molecular weight of 200,000 were added to the drum of the fluid bed granulator. Then 6.0 kg of crospovidone (polyvinylpyrrolidone) identified as K29-32 and having an average molecular weight of 40,000 was dissolved in 54.0 kg of water to prepare a binder solution. The dry material was fluid bed granulated by spraying with 18.0 kg of binder solution. The wet granules were then dried to an acceptable moisture content in a granulator and sieved using a grinder fitted with a 7-mesh sieve. The granules were then transferred to a blender and mixed with 16...
Embodiment 2
[0309] In Vitro Release Study - 16mg Hydromorphone
[0310] A series of dissolution experiments were performed using the hydromorphone tablets of Example 1 in order to evaluate the effect of alcohol on the in vitro release profile of a hydromorphone extended release dosage form according to the invention comprising 16 mg of hydromorphone as hydromorphone HCl. The release of hydromorphone hydrochloride in aqueous solutions containing 0, 4, 20 and 40% by volume of ethanol was determined over 24 hours using a Type VII dissolution bath.
[0311] The hydromorphone HCl 16 mg tablets of Example 1 were used to determine the release rate and cumulative release profile in 0%, 4%, 20% and 40% ethanol. Release rate results from the 0 month stable time point were used for 0% ethanol (water) conditions. Results for the 4%, 20% and 40% ethanol conditions were generated using additional samples from the 0 month stable time point. Release rate conditions are as follows: instrument: USP Typ...
Embodiment 3
[0328] In vitro release comparison study
[0329] As a comparison, a Type II dissolution bath was used to evaluate Palladone compared to the hydromorphone tablet of Example 1. 32 mg capsules released from vodka (27% v / v ethanol) and hydromorphone hydrochloride in water.
[0330] Dissolution parameters are as follows: dissolution apparatus: Varian VK7010 dissolution unit and VK8000 automatic sampler; medium: water and vodka (Pavlova, 40% alcohol / vol) respectively; volume: 900mL; paddle speed: 50rpm; pushing volume: 5mL; temperature : 37±0.5°C; time points: T=1, 2, 4, 6, 10, 14, 18 and 24 hours. Note: Test results show that Pavlova has only 27% alcohol.
[0331] Due to the chromatographic interference of vodka, the sample solution in vodka was evaporated before analysis, and the detailed procedure was as follows: a volume of 5 mL of sample solution was drawn into a test tube using an autosampler. After cooling to room temperature, a volume of 2 mL of the sample solution wa...
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