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Cocoa butter based suppository formulation
- 1. Jim McElroy Suppository Formulation and Manufacture
- 8. Crystal Melting Ranges of Cocoa Butter VAECK (1960) DUCK (1964) WILLIE & LOVEGREN (1966) LOVEGREN ET. AL (1976) DAVIS & DIMICK (1986) Form Temperature Form Temperature Form Temperature Form Temperature Form Temperature γ 17 γ 18 I 17.3 VI 13.0 I 13.1/17.6 ά 21-24 ά 23.5 II 23.3 V 20.0 II 17.7/19.9 III 25.5 IV 23.0 III 22.4/24.5 β' 28 β'’ 28.0 IV 27.3 III 25.0 IV 26.4/27.9 β' 33.0 V 33.8 II 30.0 V 30.7/34.4 β 34-35 β 34.4 VI 36.3 I 33.5 VI 33.8/34.1
Editor's Notes
- From Lachman et.al , “The word suppositories is derived from the Latin word suppositorium and was first used to designate this medicinal form about the seventeenth century.”
- Tween 61, Myrj 51, etc. Not enough colonic fluid to dissolve a tablet. Since the water miscible suppositories dissolve in body fluids and need not be formulated to melt at body temperature, they can be formulated with much higher melting points and thus may be safely stored at room temperature.
- If one fatty acid is attached it is a monoglyceride. If two fatty acid molecules are attached it is a diglyceride. If three are attached it is a triglyceride. Most naturally occurring lipids are triglycerides.
- If the crystal structure is not properly managed while manufacturing cocoa butter the resulting product will not harden in a reasonable amount of time or there may be post-hardening issues or considerable fat bloom.
- Gamma only forms at temperatures under 17 C Alpha forms only from gamma is present at temperatures up to 24 C Beta prime forms at temperatures above 24 C. It also forms from alpha crystals. If product does not go below 24 C only beta can form. Eventually everything goes to beta
- Poor tempering results in poor product Microscopic cracks can occur Moisture transfer in or out of the suppository Micro-fissures allow crystal migration (fat bloom) Creates a dull surface. Use examples of fat bloom and poor temper.
- All steps of the tempering process are critical.
- Milk fat also inhibits bloom.
- The IV to V transition occurs in the liquid phase only. Since the liquid phase is increased by the addition of the surfactant, this allows the transition to occur readily. The V to VI transition is hindered because there is less solid fraction due to the surfactant. Use of a surfactant causes the resulting suppository to become softer. This is because the liquid fraction is increased. That is why milk chocolate is softer than dark chocolate.
- Examples are: Aspirin, Oxymorphone HCl.
- Most OTC suppositories manufactured in the US are for hemorrhoidal preparations. For this application, a fatty base is an integral part of the therapy.
- The liver chemically modifies many drugs after absorption.
- More than half of rectally administered drugs are absorbed directly into the general circulation. The lymphatic circulation helps in absorbing the drug and diverts it from the liver.
- From 1 …and the API and its uptake by the circulatory system. From 2 …pH is a major factor.