Download FORMULA NAME: Morphine Sulfate 50−mg/mL in Pluronic

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
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__________
22 mL
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100 mL
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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.
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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
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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.
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Morphine Sulfate 50−mg/mL in Pluronic™ Lecithin Organogel
Formula # 2116 − Page 4
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