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FORMULA NUMBER: 2116 FORMULA NAME: Morphine Sulfate 50−mg/mL in Pluronic™ Lecithin Organogel DOSAGE FORM: Gel FORMULA (Rx): Ingredients For: 100 mL Lot# RPh Initials Morphine Sulfate, Anhydrous 5 g _________________________ __________ Ethoxydiglycol 5 mL _________________________ __________ 22 mL _________________________ __________ 100 mL _________________________ __________ Lecithin:Isopropyl Palmitate Solution Pluronic™ F−127 20% Gel qs SYNONYMS: Morphine Sulfate in PLO USE/TYPE: Human Use Non−Sterile Preparation CATEGORY: Analgesic and Antipyretic Misc Opiate Agonist NOTES: Calculations may be required for morphine sulfate which is generally available as the pentahydrate form. Morphine sulfate 1−mg is equivalent to morphine sulfate pentahydrate 1.135−mg. This formula provides for changes in concentrations from 1−mg/mL to 50−mg/mL to meet the clinical status of the patient. The lecithin:isopropyl palmitate solution can be prepared by mixing 0.2−g sorbic acid, 50−g of soy lecithin and 50−g of isopropyl palmitate. The Pluronic™ F−127 solution can be prepared by mixing 0.2−g sorbic acid, 20−g of Pluronic™ F−127 and sufficient purified water to make 100− mL. When counseling the patient concerning this preparation, it is advisable to explain its temperature−dependent viscosity. As the preparation is rubbed on the skin and warms, it may become slightly more viscous and resistant to rubbing. SPECIALIZED EQUIPMENT: Vortex or Magnetic Stirrer METHOD OF PREPARATION: 1. Calculate the required quantity of each ingredient for the total amount to be prepared. 2. Accurately weigh and/or measure each ingredient. 3. Dissolve the morphine sulfate in the ethoxydiglycol. 4. Add the morphine sulfate solution to about 60−mL of the Pluronic™ F−127 20% gel and mix well. 1 Morphine Sulfate 50−mg/mL in Pluronic™ Lecithin Organogel Formula # 2116 − Page 2 5. Incorporate the lecithin:isopropyl palmitate solution via shear mixing. 6. Add additional Pluronic™ F−127 20% gel to volume and continue shear mixing. 7. Package and label. LABELING: Apply Exact Dose Topically as Directed Keep Away from Eyes and Mucous Membranes Shake Well For External Use Only Keep Out of Reach of Children PRESERVATION, PACKAGING AND STORAGE: Tight, Light Resistant Container Do Not Use After ___________________ Tamper−Proof for Transport−Obtain Signature STABILITY: A beyond−use date of 30 days can be used for this preparation. ENDOTOXIN ASSESSMENT: USE: Morphine sulfate is an opium alkaloid that has been used as a prototype drug in the relief of pain. Morphine sulfate gels are used in the treatment of moderate−to−severe pain. Many hospice patients experience severe pain and must receive around−the−clock pain medications. It has been stated that, in severe pain “There is no such thing as a standard dose of morphine.” STANDARD OPERATING PROCEDURE FOR QUALITY CONTROL: Assessments may include theoretical weight compared to actual weight, pH, specific gravity, active drug assay and color. Other observations: texture−surface, texture−spatula spread, appearance, feel, rheological properties and physical macroscopic observations should be noted. REGULATORY CONTROL: United States DEA − Controlled Substance 2 Morphine Sulfate 50−mg/mL in Pluronic™ Lecithin Organogel Formula # 2116 − Page 3 REFERENCES: 1. Allen Loyd V Jr. Standard Operating Procedure for Physical Quality Assessment of Ointments/Creams/Gels. International Journal of Pharmaceutical Compounding. 2(4); 1998:309. 2. Allen Loyd V Jr. The Basics of Compounding: Compounding Gels. International Journal of Pharmaceutical Compounding. 3(5); 1999:385. 3. Ashworth Lisa D. Quality Control: Standard Operating Procedures−−An Essential Tool for Developing Quality Preparations. International Journal of Pharmaceutical Compounding. 11(3); 2007:226. 4. The United States Pharmacopeial Convention. USP−Pharmacists' Pharmacopeia. 2nd Ed., Rockville MD; 2008:775−779. 5. United States Pharmacopeia. United States Pharmacopeia 32−National Formulary 27. Chapter <795> United States Pharmacopeial Convention, Rockville MD; 2009. 6. The United States Pharmacopeial Convention. USP−Pharmacists' Pharmacopeia. 2nd Ed., Rockville MD; 2008:775−779. 7. McNulty Jack P, Muller George. Update on Managing Neuropathic Pain. International Journal of Pharmaceutical Compounding. 13(3); 2009:182. 8. Allen Loyd V Jr. Morphine Sulfate 50 mg/mL in Pluronic Lecithin Organogel. International Journal of Pharmaceutical Compounding. 13(3); 2009:244. 9. Stein C, Machelska H, Schäfer M. Peripheral analgesic and anti−inflammatory effects of opioid. Z Rheumatology. 60(6); 2001:416−424. 10. Bennett GJ. Neuropathic Pain: New insights, new interventions. Hospital Practice. 33(10); 1998:95−98, 101−104, 107−110. 11. de Leon−Cassola OA. Multimodal approaches to the management of neuropathic pain: The role of topical analgesia. Journal of Pain & Symptoms Management. 33(3); 2007:356−364. 12. Dworkin RH, O'Connor AB, Backonja M, et. al. Pharmacologic management of neuropathic pain: Evidence−based recommendations. Pain. 132(3); 2007:237−251. 13. Sawynok J. Topical analgesics in neuropathic pain. Current Pharmaceutical Design. 11(23); 2005:2995−3004. 14. Woolf CJ, Salter MW. Neuronal plasticity: Increasing the gain in pain. Science. 288(5472); 2000:1765−1769. 15. Millan MJ. The induction of pain: An integrative view. Progress in Neurobiology. 57( ); 1999:1−164. 16. Doubell TP, Mannion RJ, Woolf CJ. The dorsal horn: State dependent sensory processing, plasticity and the generation of pain. Wall PD, Melzack R, Ed. Textbook of Pain. 4th Ed. Edinburgh, Churchill Livingstone; 1999:165−181. 17. Carpenter KJ, Dickenson AH. Molecular aspects of pain research. Pharmacogenomics Journal. 2(2); 2002:87−95. 18. Stein C, Schäfer M, Machelska H. Attacking pain at its source: New perspectives on opioids. Natural Medicine. 9(8); 2003:1003−1008. 19. Kraus J, Borner C, Giannini E, et. al. Regulation of mu−opioid receptor gene transcription by interleukin−4 and influence of an allelic variation within a STAT6 transcription factor binding site. Journal of Biological Chemistry. 276(47); 2001:43901−43908. 20. Gilron I, Bailey JM, Tu D, et. al. Morphine, gabapentin, or their combination for neuropathic pain. New England Journal of Medicine. 352(13); 2005:1324−1334. 21. Rowbotham MC, Twilling L, Davies PS, et. al. Oral opioid therapy for chronic peripheral and central neuropathic pain. New England Journal of Medicine. 348(13); 2003:1223−1232. 22. Twillman RK, Long TD, Cathers TA. Treatment of painful skin ulcers with topical opioids. Journal of Pain & Symptoms Management. 17(4); 1999:288−292. 23. Fuller MA, Sajatovic M. Drug Information Handbook for Psychiatry. 7th Ed. Lexi−Comp Inc, Hudson OH; 2009:1077−1084. 3 Morphine Sulfate 50−mg/mL in Pluronic™ Lecithin Organogel Formula # 2116 − Page 4 More information about this formula and its components available at the formula section of www.CompoundingToday.com The International Journal of Pharmaceutical Compounding Inc., the parent of CompoundingToday.com, does not sponsor or initiate clinical investigations nor does it represent any agency, corporation or private individual. While a great deal of effort has been expended to ensure the accuracy of the formulations contained here, IJPC accepts no liability for loss or damage arising from reliance on the information. Compounding pharmacists using this formula take full responsibility for the formulations and hold IJPC and its officers, directors and employees harmless from any claim arising from use of or reliance on information contained therein. © 2012 International Journal of Pharmaceutical Compounding, Inc. 4