SHORT CHARACTERIZATION OF RECTAL SUPPOSITORIES CONTAINING DROTAVERINE HYDROCHLORIDE

Authors

  • R. A. VLAD George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures
  • Nicoleta-Mirela BLEBEA Ovidius University of Constanta
  • Paula ANTONOAEA George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures
  • Emőke REDAI George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures
  • Andrada PINTEA George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures
  • Cezara PINTEA George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures
  • Flavia-Ioana-Ozana Ciobanu CIOBANU George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures
  • Cornelia-Titiana COTOI George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures
  • Magdalena BIRSAN Grigore T. Popa University of Medicine and Pharmacy, Iasi, Romania
  • Adriana CIURBA George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures

DOI:

https://doi.org/10.22551/

Keywords:

DROTAVERINE, SUPPOSITORIES, MELTING POINT, UV-VIS SPECTROPHOTOMETRY

Abstract

In Romania, drotaverine formulations are only available orally or by injection. Improvements in bioavailability led to the development of rectal suppositories using three lipophilic bases. This study aimed to develop and analyze 40 mg drotaverine suppositories using semi-synthetic glycerides. The goal was to enable atraumatic administration to patients with gastrointestinal obstructions that are unsuitable for oral treatment. Materials and methods: Suppositories were cast in adult moulds using S1 (Witepsol), S2 (Lipex), and S3 (Suppocire). For the developed suppositories, the average mass and melting time (through two different methods) were measured. Drotaverine hydrochloride content was quantified using UV-Vis spectrophotometry, which had previously been checked for linearity and selectivity. Results: The unloaded suppositories were white, while those with drotaverine hydrochloride were pale yellow; all six were crack-free and weighed 1.9523-1.9884 g. Content ranged from 40.62 mg (S2) to 42.89 mg (S3). Melting time showed the same behavior for both methods, yielding values < 15 minutes in accordance with the pharmacopoeial stipulations. Conclusions: Lipophilic drotaverine suppositories were successfully produced, with physical parameters within acceptable limits. Melting time was under 30 min, meeting the recommendations of the Romanian Pharmacopeia, 10th edition. Drotaverine content was within ±7.5% of the limit. 

References

1. ***Romanian Pharmacopoeia, 10th ed.; Medical Publishing House: Bucharest, Romania, 1993; 889-890, 1066-1068.

2. ***Romanian Pharmacopoeia, 10th ed., Supplement 2004; Medical Publishing House: Bucharest, Romania, 2013; 145-150.

3. Jiao Y, Xie S, Baseer A, Ud-Din F. Rectal Administration of Celecoxib Liquid Suppositories with Enhanced Bioavailability and Safety in Rats. Curr Drug Deliv 2023; 20(2): 201-210.

4. Ge C, Wang Z, Wang Y, Wei M. Peptide-based therapeutic and delivery strategies for inflammatory bowel disease: challenges and future directions. RSC Adv 2025; 15(31): 25560-25578.

5. European Pharmacopoeia, 12th ed.; European Directorate for the Quality of Medicines & HealthCare (EDQM): Strasbourg, France, 2025.

6. Hua S. Physiological and Pharmaceutical Considerations for Rectal Drug Formulations. Front Pharmacol 2019; 10: 1196.

7. Jannin V, Lemagnen G, Gueroult P, Larrouture D, Tuleu C. Rectal route in the 21st Century to treat children. Adv Drug Deliv Rev 2014; 73: 34-49.

8. Traserra S, Barber C, Alcalá-González LG, et al. Evaluation of the mechanism of action of paracetamol, drotaverine, and peppermint oil and their effects in combination with hyoscine butylbromide on colonic motility: human ex-vivo study. Front Pharmacol 2024; 15: 1384070.

9. ANMDMR – Nomenclator Medicamente (accessed May 29, 2026).

10. DiPiro JT, Yee GC, Posey LM, et al. Pharmacotherapy: A Pathophysiologic Approach, 11th ed.; McGraw-Hill Education: New York, USA, 2019.

11. Ikeotuonye AC, Umeora OJ, Nwafor JI, Ojumah BO, EkwunifeIC, Dimejesi IB. Drotaverine to shorten the duration of labourin primigravidas: A randomized, double-blind, placebo-controlled trial. Afr Health Sci 2022; 22: 108-116.

12. Rai RR, Dwivedi M, Kumar N. Efficacy and safety of drotaverine hydrochloride in irritable bowel syndrome: a randomized double-blind placebo-controlled study. Saudi J Gastroenterol 2014; 20(6): 378-382.

13. Eder P, Kowalski P, Mastalerz-Migas A, et al. Self-medication with drotaverine among patients with common abdominal symptoms and treatment efficacy from the perspectives of patients and general practitioners-an observational, retrospective, cross-sectional study using real-world data. Journal of Clinical Medicine 2022; 11: 1-9.

14. Ciurba A, Todoran N, Tăurean A, et al. Kinetic analysis of in vitro drug release from valproic acid and sodium valproate suppositories. Farmacia 2014; 62(6):1143-1156.

15. Sultan T, Hamid S, Hassan S, et al. Development and evaluation of immediate release diclofenac sodium suppositories. Pak J Pharm Sci 2018; 31(5): 1791-1795.

16. Chen J, Deng W, Li X, Wang X, et al. Hexafluoroisopropanol / Brij-35 Based Supra-molecular Solvent for Liquid-Phase Microextraction of Parabens in Different Matrix Samples, Journal Cromatogr 2019, 1591: 33-43.

17. Purohit TJ, Hanning SM, Wu Z. Advances in rectal drug delivery systems. Pharm Dev Technol 2018; 23(10): 942-952.

18. Narang M, Shah, Akhtar H - Efficacy and Safety of Drotaverine Hydrochloride in Children with Recurrent Abdominal Pain: A Randomized Placebo Controlled Trial, Indian Pediatr., 2015; 52(10): 847-851.

19. Vlad R-A, Pintea C, Chirteș D-A, et al. The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations. Pharmaceutics. 2023; 15(8): 2147.

Additional Files

Published

2026-09-28

Issue

Vol. 130 No. 3 (2026): The Medical-Surgical Journal

Section

PHARMACY

License

Copyright (c) 2026 The Medical-Surgical Journal

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

COPYRIGHT 
Once an article is accepted for publication, MSJ requests a transfer of copyrights for published articles.

COPYRIGHT TRANSFER FORM FOR 

REVISTA MEDICO-CHIRURGICALĂ A SOCIETĂȚII DE MEDICI ȘI NATURALIȘTI DIN IAȘI /

THE MEDICAL-SURGICAL JOURNAL OF THE SOCIETY OF PHYSICIANS AND NATURALISTS FROM IASI

We, the undersigned authors of the manuscript entitled

_____________________________________________________________________________________

_____________________________________________________________________________________

warrant that this manuscript, which is submitted for publication in the REVISTA MEDICO-CHIRURGICALĂ, has not been published and it is not under consideration for publication in another journal.

  1. we give the consent for publication in the REVISTA MEDICO-CHIRURGICALĂ, in printed and electronic format and we transfer unconditioned and complete the copyright of this manuscript to the REVISTA MEDICO-CHIRURGICALĂ, in the event of its acceptance.
  2. the manuscript does not break the intellectual property rights of any other person.
  3. we have read the submitted version of the manuscript and we are fully responsible for the content.

Names and signatures of authors / copyright owners (the following sequence is the authorship of the article):

  1. ______________________________/_________________________
  2. ______________________________/_________________________
  3. ______________________________/_________________________

N.B.  All the authors must sign this form