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Stability Indicating Analytical Method Development and Validation for the Simultaneous Determination of Degradation Impurities of Buprenorphine and Naloxone in Combination Pharmaceutical Dosage Form by RP-HPLC  [PDF]
Praveen Rao Balguri, Harish Kumar Cherivirala
American Journal of Analytical Chemistry (AJAC) , 2025, DOI: 10.4236/ajac.2025.1610015
Abstract: A stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous quantitative determination of degradation products of Buprenorphine and Naloxone in a combination pharmaceutical dosage form. Efficient chromatographic separation was achieved using gradient elution with mixture of acetonitrile and 50 mM potassium phosphate monobasic buffer (adjusted to pH 4.5 with diluted phosphoric acid) as mobile phase A, and acetonitrile as mobile phase B. The separation was performed on a Phenomenex Luna C18 column (4.6 × 100 mm, 3 μm). UV detection was carried out at 280 nm, with flow rates of 1.1 mL/min and 1.2 mL/min. The method was validated in accordance with ICH guidelines to demonstrate specificity, linearity, limits of detection and quantitation, precision, accuracy, robustness, and solution stability. This validated method was successfully applied for the simultaneous quantitative determination of degradation products of Buprenorphine and Naloxone in the combination dosage form during both release testing and shelf-life stability studies.
Development and Implementation of Tennessee Nonresidential Buprenorphine Treatment Guidelines
BCPP,Erica Schlesinger,Howard L Burley Jr.,Kenneth C Hohmeier,M.D.,PharmD.,Wesley Geminn
- , 2018, DOI: https://doi.org/10.24926/iip.v9i3.1317
Abstract: Abstract Objective: To describe the recent legislation in Tennessee and subsequent development and implementation of state-wide buprenorphine treatment guidelines. Practice Innovation: In 2016, Tennessee began licensing office-based opioid treatment (OBOT) clinics. Due to initial licensing criteria, not all providers were required to be licensed with the Department of Mental Health and Substance Abuse Services (TDMHSAS). The gap in licensing made it difficult to ensure an appropriate standard of care was being met by all addiction treatment providers. Therefore, the state developed legislation that allowed for the creation of best practice guidelines to encompass all providers of buprenorphine in the state of Tennessee, not just the licensed OBOT clinics. The guidelines define what the standard of care should entail while treating this vulnerable addiction population. Results: Tennessee legislation granted the formation of a committee to create the Tennessee Nonresidential Buprenorphine Treatment Guidelines. The committee was comprised of physicians, pharmacists, lawyers, law enforcement, and state officials. The finalized guidelines were published and effective January 1, 2018, and adopted as policy by the boards of medical examiners, osteopathic examination, and pharmacy shortly thereafter. The guidelines are now enforceable by the boards and give them the ability to discipline physicians who practice outside the standard of care. Conclusion: Tennessee legislation provides a model for other states to take action in combating this opioid crisis by not only increasing access to addiction treatment, but increasing access to quality care. Article Type: Commentar
Comparison of Buprenorphine and Buprenorphine/naloxone in Detoxification of Opioid-dependent Men
Hassan Ziaaddini,Mahboobeh Mousavi-Ramezanzade,Maryam Chegeni,Shahrzad Mazhari,Shima Heshmati
- , 2018, DOI: 10.22122/ahj.v10i4.679
Abstract: Buprenorphine sublingual tablets are now available in Iran for opioid detoxification in clinics. Aim of the present study was to compare the efficiency of buprenorphine with buprenorphine/naloxone in short-term detoxification in a group of Iranian male opioid-dependent patients
Clinical Assessment of the Use of Propinox Hydrochloride and Scopolamine Hydrochloride in the Treatment of Abdominal Colic: A Retrospective, Comparative Study  [PDF]
Helio Rzetelna, Carlos Frederico Porto Alegre Rosa, Mario Kirzner, Lucas Pereira Jorge de Medeiros, Camila Melo, Marcia Gon？alves Ribeiro, Lisa Oliveira, José Galv？o Alves, Mauro Geller
International Journal of Clinical Medicine (IJCM) , 2016, DOI: 10.4236/ijcm.2016.77052
Abstract: Objectives: The purpose of this study was to evaluate and compare the use of propinox hydrochloride and scopolamine hydrochloride in patients presenting abdominal colic (abdominal pain), in terms of treatment efficacy and tolerability. Material & Methods: This was an analytical, retrospective, comparative study based on hospital records of outpatients treated at Serviço de Clínica Médica do Hospital das Clínicas Costantino Otaviano (HCTCO) and at Santa Casa de Misericórdia do Rio de Janeiro, from 1988-1998. Subjects were divided into two groups: patients from Group 1 were treated with propinox hydrochloride, while patients from Group 2 were treated with scopolamine hydrochloride. Statistical analysis was performed using GraphPad Prism version 5.0. For comparison of categorical variables, we used the chi-squared or Fisher’s test, while continuous variables were analyzed using ANOVA or the Student’s T test. Results: A total of 1042 subjects were included, of which 525 were allocated to Group 1 and 517 to Group 2. Mean treatment duration was 9.166 days (±4.208) in Group 1 and 8.795 days (±5.052) in Group 2, with no statistically significant difference in treatment duration between the two groups (p = 0.198). All subjects in Group 1 were treated with propinox 10 mg (2 coated tablets, three times per day) while all subjects in Group 2 were treated with scopolamine hydrochloride 10 mg (2 coated tablets, three times per day). There were no statistically significant between-group differences in weight, BMI, heart rate, and respiratory rate at pre- and post-treatment; with the exception of higher post-treatment systolic blood pressure in Group 1, blood pressure measures also remained homogenous. Adverse events were reported among both treatment groups with no significant between-group difference in incidence (p = 0566). At pretreatment, pain intensity was more severe in Group 1 (p = 0.0257), while at post-treatment, there was no statistically significant difference between the two treatment groups (p = 0.895). There was a statistically significant improvement in pain intensity within both treatment groups (χ2 = 631.4; df = 3; p < 0.0001 for Group 1 and χ2 = 554.3; df = 3; p < 0.0001 for Group 2). Conclusion: The results obtained in this study indicate a therapeutic equivalence between propinox hydrochloride and scopolamine hydrochloride. Both treatments demonstrated good efficacy and tolerability in the treatment of abdominal colic pain, in the population evaluated.
Life after Addiction—Post-Operative Pain Management in an Obstetrical Patient on Long-Term Buprenorphine Therapy  [PDF]
Kelly R Bowen, Jonathan D Baum
Open Journal of Obstetrics and Gynecology (OJOG) , 2017, DOI: 10.4236/ojog.2017.79096
Abstract: A G6P2032 female, prior cesarean x3 with history of opioid addiction maintained on buprenorphine presented for scheduled repeat cesarean section. Pre-operatively, her maintenance dose of medication was held secondary to concerns for partial agonist effect. Post-operative pain control was suboptimal with the patient ultimately proceeding to withdrawal. Doses of hydromorphone were titrated to 10 mg every 3 hours to avoid further withdrawal. Review of expert opinion after discharge recommended against holding buprenorphine therapy in the post-operative period. Pain management options include maintenance therapy with additional doses of opioid and non-opioid pain relieving medications.
Analytical Stability Indicative Method Development and Validation by High Pressure Liquid Chromatography for Assay in Ciprofloxacin hydrochloride Drug Substances  [PDF]
S. Shrinivas, M. Revanasiddappa
American Journal of Analytical Chemistry (AJAC) , 2015, DOI: 10.4236/ajac.2015.69069
Abstract: Ciprofloxacin is an antibiotic generic drug that can treat a number of bacterial infections. It is a second generic fluoroquinolone. This work presents a simple, sensitive and stability indicative method for assay determination of drug substances ciprofloxacin hydrochloride by high pressure liquid chromatography (HPLC). Separation of impurities from the main drug substances and accurate assay quantification with a simple method is difficult by Spectrophotometry. The separation of co-eluents and impurities from the ciprofloxacin drug substances was archived by HPLC with simple mobile phase 0.15% orthophosphoric acid adjusted pH to 3.0 with triethylamine and acetonitrile using a gradient program, column inertsil C18, 250 mm × 4.0 mm, 5 μm. Flow rate was 0.7 mL/min, the column temperature and injection volume were 35°C and 10.0 μL. Chromato-graphic analysis was carried out at wavelength 278 nm. The developed method was validated according to the international conference on harmonization (ICH) guidelines regarding: Precision, specificity by degradation, linearity, accuracy, range and robustness. The proposed method showed good linearity (correlation coefficient and regression coefficient were not less than 0.999 and 0.998) in the range of 50% to 150% of working concentration. The recovery at 50%, 100% and 150% of working concentration level was within 98.0% to 102.0%. The range of the method is concluded that developed method is from 50% to 150% of target concentration for ciprofloxacin hydrochloride. The applicability of the proposed method was verified through the analysis of the samples and percentage recoveries in the range of 98% to 102% were obtained without any interference detected at the main peak in the chromatogram. The validated method is highly selective, simple, accurate, cost effective, and it is applicable for stability studies and routine quality-control analysis in the pharmaceutical industries.
Buprenorphine Rescue in Acute Opioid Toxicity: An Alternative to Naloxone Infusion  [PDF]
Bryden Urie, Sandra Stover, Robert Pueringer
Case Reports in Clinical Medicine (CRCM) , 2025, DOI: 10.4236/crcm.2025.1410071
Abstract: Following an opioid overdose, repeated doses of naloxone are often administered in the Emergency Department (ED) for recurrent opioid toxicity. Naloxone infusions are often started after several doses of naloxone, which are challenging to titrate, can lead to sustained periods of precipitated withdrawal, and often result in hospital admission. In this case report, we use initiation of buprenorphine as an alternative to a naloxone infusion following acute opioid toxicity in the ED while also demonstrating the transition of care of Opioid Use Disorder (OUD) in the ED setting to long-term outpatient management. Currently, we see high rates of recurrent opioid toxicity post naloxone administration in this setting, emphasizing the need for an alternative approach.
Transdermal buprenorphine – a critical appraisal of its role in pain management
Guy Hans, Dominique Robert
Journal of Pain Research , 2009, DOI: http://dx.doi.org/10.2147/JPR.S6503
Abstract: ansdermal buprenorphine – a critical appraisal of its role in pain management Review (7257) Total Article Views Authors: Guy Hans, Dominique Robert Published Date September 2009 Volume 2009:2 Pages 117 - 134 DOI: http://dx.doi.org/10.2147/JPR.S6503 Guy Hans1,2, Dominique Robert3 1Multidisciplinary Pain Center, 2Department of Anesthesiology, 3Department of Critical Care Medicine, Antwerp University Hospital, Edegem, Belgium Abstract: This paper reviews the current clinical data for the role of transdermal buprenorphine (BUP TDS) in the treatment of diverse acute and chronic pain syndromes. Literature searches were carried out using PubMed (1988 to June 2009). The published findings seem to support hypotheses regarding the rather unique analgesic mechanisms of buprenorphine as compared with pure μ-opioids like morphine and fentanyl. However, the exact mechanism of this analgesic efficacy still remains largely unknown despite recent advances in preclinical pharmacological studies. Such assessments have demonstrated the sustained antihyperalgesic effect of buprenorphine in diverse animal pain models. These findings are supported in a growing number of clinical studies of oral, intrathecal, intravenous, and BUP TDS. This review paper focuses almost entirely on the clinical experience concerning the transdermal administration of buprenorphine, although preclinical aspects are also addressed in order to provide a complete picture of the unique pharmacological properties of this analgesic drug. Mounting evidence indicates the appropriateness of BUP TDS in the treatment of diverse acute and chronic pain syndromes which have been less or not responsive to other opioids. Additionally, BUP TDS seems to hold great promise for other difficult-to-treat (pain) conditions, such as patients in the intensive care setting. However, its use is somewhat tempered by the occurrence of local skin reactions which have been shown to be often therapy resistant. Further studies are certainly warranted to identify even more precisely the clinical syndromes that are most sensitive to buprenorphine treatment, and to compare buprenorphine to other opioids in head-to-head trials of acute and chronic pain conditions.
A Comparison of Buprenorphine and Methadone Treatment of Heroine Dependency
Iraj Shahramian,Abdolvahab Moradi,Lila Roosta,Malek Rakhshani
Pakistan Journal of Biological Sciences , 2005,
Abstract: At the present time heroine dependency is treated by methadone. In order to determine the effectiveness of another medicine named buprenorphine, an interventional study has been carried out. In this interventional study of 70 patients, compared buprenorphine (2 mg) and low dose (20 mg) methadone as treatment for heroine dependence. Buprenorphine and methadone were administered daily for 15 days. There were 35 patients in each group. Comparison between groups for withdrawal sign and symptoms showed no significant differences. As compared with low-dose methadone and buprenorphine, it was shown that buprenorphine is a suitable treatment for heroine addiction in terms of decreased withdrawal sign and symptoms.
POSTOPERATIVE ANALGESIA
MANZOOR AHMED FARIDI
The Professional Medical Journal , 2004,
Abstract: Objective: To determine the effectiveness of sublingual buprenorphinein terms of duration of action, quality of analgesia, convenience of administration and safety, as compared tointramuscular morphine for postoperative analgesia after abdominal hysterectomy. Design: Prospective,randomized and comparative study. Place and duration of study: Combined Military Hospital Jhelum, fromJanuary, 2001 to October, 2003. Subjects and methods: Women undergoing abdominal hysterectomy wererandomly assigned to receive postoperative analgesia with sublingual buprenorphine 0.007 mg/kg body weightor intramuscular morphine 0.2 mg/kg body weight. No analgesic was used before or during anaesthesia. Firstdose of analgesic was given when patients complained of pain after recovery and doses repeated on requiredbasis. Main outcome measures was effectiveness of analgesia as measured by modified VAS and four pointverbal rating scale. Secondary outcome measures were degree of sedation, respiratory rate and blood pressure.Results: Both drugs provided effective postoperative analgesia but buprenorphine provided slightly better painrelief for a much longer duration and thus required fewer doses (p=.ooo as determined by Pearson chi-squaretest ). Onset of action was slower for buprenorphine (36.8±5.7 mins) as compared to morphine (12.2±2.7 mins).Mean arterial blood pressure remained stable in buprenorphine group but slightly decreased in morphine group.Respiratory rate slightly reduced in both groups. The incidence of adverse reactions like nausea, vomiting anddrowsiness were slightly more common in buprenorphine as compared to morphine group. Conclusion: Bothdrugs provide equally effective postoperative analgesia. Ease of administration and longer duration of actionof sublingual buprenorphine make it a more acceptable option.
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