Strength, efficacy and tolerability of morphine solution with and without added preservatives: A comparative study
DOI:
https://doi.org/10.3329/bjp.v10i1.21754Keywords:
Morphine, Palliative CareAbstract
Cancer patients having moderate to severe pain need immediate pain relief. Immediate release formulation of morphine is not available in Bangladesh. This open label randomised two phase crossover clinical trial was conducted to compare strength, efficacy, and tolerability of oral morphine solution prepared from morphine sulfate injectable formulation and sustained release tablet with and without added preservatives. Concentration of morphine in solutions both with and without added preservative was highest on the first day and then gradually decreased. No difference between two storage temperatures on first day, but highly significant difference afterwards. Rate of degradation of morphine in solution with added preservative was significantly slower. The present study revealed that the solutions prepared from sustained release tablets and injectable formulation with added preservative could be an option to control severe pain in cancer patients. To introduce the present research finding in clinical practice, this has to be accepted institutionally.
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References
Afreen S, Rahman MS. Adherence to treatment guidelines in a university hospital: Exploration of facts and factors. Bangladesh J Pharmacol. 2014: 9: 182-88.
Arkinstall WW, Goughnour BR, White JA, Stewart JH. Control of severe pain with sustained-release morphine tablets v. oral morphine solution. CMAJ. 1989; 140: 653-61.
Begum M, Rahman MS, Islam AFMS, Khan IA, Akhter N. Eleven years of the undergraduate medical curriculum 1988: Review on the changes in pharmacology written questions. Bangladesh J Physiol Pharmacol. 1999: 15: 27-30.
British Pharmacopeia commission 2009, British Pharmacopeia, the stationary office, United Kingdom.
Chowdhury RZ, Islam MS, Rahman MS. Pharmacokinetic parameters of amoxicillin in Bangladeshi volunteers: A preliminary evaluation. Bangladesh J Physiol Pharmacol. 2010: 26: 1-9.
Chowdhury RZ, Islam MS, Rahman MS. Pharmacokinetic parameters of ciprofloxacin in Bangladeshi volunteers: A preliminary evaluation. Bangladesh J Physiol Pharmacol. 2011: 27: 1-8.
Chowdhury RZ, Islam MS, Rahman MS. Pharmacokinetic study after single oral dose of beta-lactam and fluoroquinolone antimicrobials in Bangladeshi healthy male volunteers. Bangladesh J Physiol Pharmacol. 2014: 30: 16-24.
Christensen KS, Cohen AE, Mermelstein FH, Hamilton DA, McNicol E, Babul N, Carr DB. The analgesic efficacy and safety of a novel intranasal morphine formulation (morphine plus chitosan), immediate release oral morphine, intravenous morphine, and placebo in a postsurgical dental pain model. Anesth Anal. 2008; 107: 2018-24.
Colluze PH, Schwertzberg L, Conroy JD, Charapata S, Gay M, Busch MA, Chave J, Ashley J, Lebo D, McCracken M, Portenoy RK. Breakthrough cancer pain: A rendomized trial comparing oral transmucosal fentanyl citrate and morphine sulphate immediate release. Pain 2001; 91: 123-30.
Conno FD, Ripamonti C, Fagnoni E, Brunelli C. The MERITO Study: A multicentre trial of the analgesic effect and tolerability of normal-release oral morphine during titration phase in patients with cancer pain. Palliat Med. 2008; 22: 21421
Dale O, Piribour M, Kassa S, Moksness K, Klepstad P. A double-blind, randomized, crossover comparison between single-dose and double-dose immediete-release oral morphine at bedtimein cancer patients. J Pain Symptom Manage. 2009; 37: 68-76.
Dehgan R, Ramakrichnan J, Ahmed N, Harding R. The use of morphine to control pain in advanced cancer: An investigation of clinical usage in Bangladesh. Palliat Med. 2010; 24: 707-14.
Deschamps M, Band PR, Hislop TG, Rusthoven J, Iscoe N, Warr D. The evaluation of analgesic effects in cancer patients as exemplified by a double-blind, crossover study of immediate-release versus controlled-release morphine. J Pain Symptom Manage. 1992; 7: 384-92.
Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. Studies with pain rating scales. Ann Rheum Dis. 1978; 37: 378-81.
Eyelede OR, Ajayi IO, Elumelu TN, Soyannwo OA, Akinyemi OA. Oral morphine effectiveness in Nigerian patients with advanced cancer. J Pain Palliat Care Pharmacother. 2012; 26: 24-29.
Finn JW, Walsh TD, MacDonald N, Bruera E, Krebs LU, Shepard KV. Placebo-blinded study of morphine sulphate sustained-release tablets and immediate-release morphine sulphate solution in outpatients with chronic pain due to advanced cancer. J Clin Oncol. 1993; 11: 967-72.
Grassby PF, Hutchings L. Factors affecting the physical and chemical stability of morphine sulphate solutions stored in syringes. Int J Pharm Pract. 1993; 2: 39-43.
Hagen NA, Biondo P, Stiles C. Assessment and management of breakthrough pain in cancer patients: Current approaches and emerging research. Curr Pain Headache Rep. 2008; 12: 241-48.
Hanks GW, Conno FD, Cherny N, Hanna M, Kalso E, McQuay HJ, Mercadante S, Meynadier J, Poulain P, Ripamonti C, Radbruch L, I Casas J Roca, Sawe J, Twycross RG, Ventafridda V. Morphine and alternative opioids in cancer pain: The EAPC recommendation. Br J Cancer. 2001; 84: 587-93.
Kamuhabwa A, Ezekiel D. Rational use and effectiveness of morphine in the palliative care of cancer patients at the Ocean Road Cancer Institute in De res salaam, Tanzania. Tanzan J Health Res. 2009; 11: 171- 74.
Khatun S, Molla MR, Akhtaruzzaman AKM, Rahman MS. Effectiveness of multimodal preemptive analgesic therapy in maxillofacial surgery. Bangladesh J Physiol Pharmacol. 2008: 24: 17-24.
Kumar KS, Rajagopal MR, Naseema AM. Intravenous mor-phine for emergency treatment of cancer pain. Palliat Med. 2000; 14: 183-88.
Lawrence AT, Quanyun A, Lien P. Physical and chemical stability of morphine sulphate 5- mg/mL and 50- mg/mL packaged in plastic syringe. Int J Pharm Compd. 2002; 6: 7073.
Lee G, Sabra K, Doyle L, Doyle N, O Malley G. Stability of morphine sulphate in PCAs. EJHP. 2003; 1-3.
Likert R. A technique for the measurement of attitudes. Arch Psych. 1932; 22: 1-55.
Melzack R, Mount BM, Gordon GM. The brompton mixture versus morphine solution given orally: Effects on pain. Can Med Assoc J. 1979; 120: 435-38.
Preechagoon D, Sumyai V, Tontisirin K, Aumpon S, Pongjan-yakul T. Formulation development and stability testing of oral morphine solution utilizing preformulation approach. J Parm Pharmaceut Sci. 2005; 8: 362-69.
Quigley C, Joel S, Patel N, Baksh A, Slevin M. Plasma concentration of morphine, morphine-6-glucoronide and morphine-3-glucoronide and their relationship with analgesia and side effects in patients with cancer-related pain. Palliat Med. 2003; 17: 185- 90.
Rahman MS. Changes required in pharmacotherapy teaching to ensure rational use of drugs. Bangladesh J Physiol Pharmacol. 1995: 11: 38-39.
Rahman MS, Kamal ASMA, Chowdhury S, Khan IA, Islam AMZ, Sultana R, Begum M, Akhter N, Anwar AKMN. Exercise on selection of P-drug: Preliminary evaluation of a newer method of pharmacotherapy teaching in Bangladesh. Bangladesh J Physiol Pharmacol. 2000: 16: 50-54.
Rahman MS, Huda S. Antimicrobial resistance and related issues: An overview of Bangladesh situation. Bangladesh J Pharmacol. 2014: 9: 218-24.
Scott J, Huskisson EC. Vertical or horizontal visual analogue scales. Ann Rheum Dis. 1979; 38: 560.
Todd J, Rees E, Gwillium B, Davis A. An assessment of the efficacy and tolerability of a double dose of normal-release morphine sulphate at bedtime. Palliat Med. 2002; 16: 507-12.
Vermeire A, Remon JP. Stability and compatibility of morphine. Int J Pharm. 1999; 187: 17-51.
World Health Organization (WHO). World Health Organization cancer pain relief with a guide to opioid availability. 2nd ed. Geneva, WHO, 1996.
Yeh SY, Lach JL. Stability of morphine in aqueous solution. III. Kinetics of morphine degradation in aqueous solution. J Pharm Sci. 1961; 50: 35-42.
Zeppetella G. Impact and management of breakthrough pain in cancer. Curr Opin Support Palliat Care. 2009; 3: 16.
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