Release of Morphine Sulfate from Compounded Slow-Release Capsules: The Effect of Formulation on Release
Author(s): Bogner Robin H, Szwejkowski Jessica, Houston Alana
Issue: Sep/Oct 2001 - Bioidentical Hormone Replacement Therapy
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Page(s): 401-405
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Abstract: Morphine sulfate is often used to treat severe pain. Pharmacists
have been requested to compound morphine sulfate sustained-
release capsules in dosages that are not available commercially.
However, there has been considerable controversy
about the advisability of that practice. This study determined
the release of six formulations of 300 mg morphine sulfate sustained-
release capsules by means of a United States Pharmacopeia
(USP) type III dissolution apparatus. The formulation
suggested by a reputable compounding consulting company
released almost half the morphine in the first hour of a timerelease
test and did not adequately sustain the release of the remainder.
With increases in the level of hydroxypropyl methylcellulose
(Methocel), the release was prolonged and the amount
of drug released during the first hour was reduced. One formulation
of encapsulated compressed pellets showed that
the release could be sustained significantly beyond that of the
original formulation. In addition, the increased agitation that
occurs in the gastrointestinal tract when the medication is taken
after a meal reduced the period of sustained release and slightly
increased the amount of morphine released during the first
hour after administration. In conclusion, the original formula
of morphine sulfate sustained-release capsules (Formula A)
is probably not adequate for most applications. The formulations
with a greater percentage of Methocel are preferred. In
addition, the pelleted formulation was superior; however, it
may not be feasible to use this labor-intensive approach to compound
capsules.
Related Keywords:
Morphine sulfate, slow-release capsules, effect of formulation on
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