49.Issue 10 october 25 - INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES

Volume : 12, Issue : 10, October – 2025

Title:

PHARMACEUTICAL ELIXIRS AND TINCTURES:
A REVIEW ON ALCOHOL-BASED ORAL LIQUID FORMULATIONS

Authors :

Komal Bhimrao Chandanshive*, Akanksha babaso Bharane, Nikita Dhanaji Bharane, Prachiti Vasant Katkar,

Abstract :

Alcohol-based oral liquid formulations such as elixirs and tinctures represent some of the earliest and most versatile dosage forms in pharmaceutical practice. Traditionally used as solvent systems for herbal and synthetic drugs, these preparations continue to hold clinical and industrial relevance due to their enhanced solubility, stability, and patient acceptability. This review provides a comprehensive overview of the formulation science, classification, composition, and manufacturing of tinctures and elixirs, highlighting the roles of ethanol and co-solvents in drug solubilization, preservation, and extraction. The discussion encompasses the source materials, including both botanical extracts and pure APIs, and explores the techniques of maceration, percolation, ultrasonic, and microwave-assisted extraction used in their preparation. Key physicochemical and stability aspects, such as solubility behavior, precipitation risks, and ethanol volatilization, are analyzed in relation to formulation quality and shelf life. Furthermore, the review summarizes pharmacopeial tests, analytical assays (HPLC, GC, LC–MS), and method validation parameters essential for ensuring product consistency and compliance with regulatory standards. With the growing interest in herbal therapeutics and patient-friendly liquid dosage forms, understanding the science behind alcohol-based preparations is vital for developing modern, standardized, and safe formulations that bridge traditional pharmacognosy and contemporary pharmaceutics.
Keywords: Elixirs; Tinctures; Alcohol-based formulations; Hydroalcoholic extraction; Ethanol; Solubility; Stability; Quality control; Analytical methods; Pharmacopeial standards.

Cite This Article:

Please cite this article in press Komal Bhimrao Chandanshive et al., pharmaceutical elixirs and tinctures:
A review on alcohol-based oral liquid formulations, Indo Am. J. P. Sci, 2025; 12(10).

REFERENCES:

1. Lachman L, Lieberman HA, Kanig JL. The Theory and Practice of Industrial Pharmacy. 3rd ed. Mumbai: Varghese Publishing House; 1987.
2. Allen LV Jr, Popovich NG, Ansel HC. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. 11th ed. Philadelphia: Lippincott Williams & Wilkins; 2018.
3. Rowe RC, Sheskey PJ, Quinn ME, editors. Handbook of Pharmaceutical Excipients. 7th ed. London: The Pharmaceutical Press; 2017.
4. Lachman L, Lieberman HA, Kanig JL. Elixirs and tinctures. In: The Theory and Practice of Industrial Pharmacy. 3rd ed. Mumbai: Varghese Publishing House; 1987. p. 452–60.
5. British Pharmacopoeia Commission. British Pharmacopoeia. London: The Stationery Office; 2023.
6. United States Pharmacopeial Convention. USP–NF 2023. Rockville (MD): United States Pharmacopeial Convention; 2023.
7. Indian Pharmacopoeia Commission. Indian Pharmacopoeia. Ghaziabad: Government of India; 2022.
8. Kumar MN. Handbook of Herbal Medicine and Extracts. 1st ed. New Delhi: Pharma Publications; 2015.
9. Eldridge RC. Alcohol as a solvent in pharmaceutical preparations. J Pharm Sci. 1965;54(9):1251–6.
10. Martin A, Sinko PJ, editors. Martin’s Physical Pharmacy and Pharmaceutical Sciences. 7th ed. Philadelphia: Lippincott Williams & Wilkins; 2017.
11. Thakur RB, Tiwari S. Solubility enhancement of poorly water soluble drugs via co-solvent systems: a review. Int J Pharm Sci Rev Res. 2012;14(1):17–23.
12. Kaur LP, Arora G. Excipients: role in pharmaceutical formulations. Asian J Pharm Clin Res. 2017;10(3):27–33.
13. Mukherjee PK. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. 1st ed. New Delhi: Business Horizons; 2002.
14. Bhatia MS, Gupta GN. Analytical methods for herbal constituents: chromatography and spectroscopy approaches. Pharmacogn Rev. 2011;5(9):37–46.
15. United States Food and Drug Administration. Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics. Silver Spring, MD: FDA; 2015.
16. ICH Steering Committee. ICH Q2(R2) Validation of Analytical Procedures: Text and Methodology. Geneva: International Council for Harmonisation; 2019.
17. Brittain HG, editor. Profiles of Drug Substances, Excipients, and Related Methodology. Vol. 45. Amsterdam: Academic Press; 2020.
18. Carter SJ, editor. Cooley’s Cyclopaedia of Pharmaceutical Technology. 3rd ed. New York: Informa Healthcare; 2007.
19. Gupta S, Kesarla R, Omri A. Formulation strategies to improve solubility of poorly soluble drugs. ISRN Pharm. 2013;2013:Article ID 105-011.
20. Prasad YV. Stability testing of pharmaceuticals: a practical approach. Pharm Technol. 2006;30(4):48–63.
21. Lachman L. Tinctures and fluidextracts. In: The Theory and Practice of Industrial Pharmacy. 3rd ed. Mumbai: Varghese Publishing House; 1987. p. 461–8.
22. Jadhav VN, Kuchekar BS. Herbal tinctures: standardization and regulatory scenario. Int J Pharm Pharm Sci. 2015;7(4):30–8.
23. Hundekari S. A simple guide to quality control for liquid dosage forms. Int J Pharm Res Dev. 2020;12(4):2402–13. ijprdjournal.com
24. United States Pharmacopeial Convention. USP–NF 2023. Rockville (MD): United States Pharmacopeial Convention; 2023. USPNF
25. British Pharmacopoeia Commission. British Pharmacopoeia. London: The Stationery Office; 2023.
26. Indian Pharmacopoeia Commission. Indian Pharmacopoeia. Ghaziabad: Government of India; 2022.
27. Shafique S. Quality control tests for syrups and elixirs. Course Hero. 2021. Available from: https://www.coursehero.com/file/79018923/Quality-control-tests-for-syrups-and-elixirspptx-NEWpptx/
28. Pharmacy180. Review questions answers – Pharmaceutical solutions. Pharmacy180. Available from: https://www.pharmacy180.com/article/review-questions-answers-2822/
29. Mohiuddin AK. Extemporaneous compounding: Selective pharmacists. Pharmaceutica Analytica Acta. 2019;10(5):1–3. PMC
30. United States Food and Drug Administration. Drug quality sampling and testing programs. FDA. 2025. Available from: https://www.fda.gov/drugs/science-and-research-drugs/drug-quality-sampling-and-testing-programs
31. University of Basrah. Mixed solvent systems; spirits, and elixirs. College of Pharmacy. 2016. Available from: https://www.pharmacy.uobasrah.edu.iq/images/stage_three/Pharmaceutical_Technology_I/3%20Elixirs.pdf
32. PharmacyLabs. Pharmaceutical solutions II: Nonaqueous solutions. PharmLabs. Available from: https://pharmlabs.unc.edu/labexercises/compounding/pharmsol2/
33. Studocu. Elixirs: Comprehensive guide to formulation and uses. Studocu. 2023. Available from: https://www.studocu.com/row/document/riphah-international-university/pharmaceutical-chemistry/elixirs-detail-about-elixir/115480176
34. Course Hero. Quality control tests for syrups and elixirs. Course Hero. Available from: https://www.coursehero.com/file/79018923/Quality-control-tests-for-syrups-and-elixirspptx-NEWpptx/
35. Scribd. Quality control tests for emulsions, syrups, tinctures, elixirs, ointments, and others. Scribd. Available from: https://www.scribd.com/document/372048934/Quality-Control-Tests-for-Emulsions-Syrups-Tinctures-Elixirs-Ointments-and-Others
36. Scribd. Quality control tests for syrups and elixirs. Scribd. Available from: https://www.scribd.com/document/509844378/QUALITY-CONTROL-TESTS-FOR-SYRUPS-12554664
37. Scribd. QC hands out syrups and elixirs. Scribd. Available from: https://www.scribd.com/document/805284412/QC-Hands-Out-Syrups-and-Elixirs
38. Pharmacy180. Review questions answers – Pharmaceutical solutions. Pharmacy180. Available from: https://www.pharmacy180.com/article/review-questions-answers-2822/
39. Studocu. Elixirs: Comprehensive guide to formulation and uses. Studocu. 2023. Available from: https://www.studocu.com/row/document/riphah-international-university/pharmaceutical-chemistry/elixirs-detail-about-elixir/115480176
40. PharmacyLabs. Pharmaceutical solutions II: Nonaqueous solutions. PharmLabs. Available from: https://pharmlabs.unc.edu/labexercises/compounding/pharmsol2/
41. United States Pharmacopeial Convention. USP–NF 2023. Rockville (MD): United States Pharmacopeial Convention; 2023. USPNF
42. British Pharmacopoeia Commission. British Pharmacopoeia. London: The Stationery Office; 2023.
43. Singh R, Shukhla P, Kumar V. Stability-indicating HPLC method for quantification of marker compounds in herbal preparations. J Chromatogr Sci. 2018;56(7):537–45.
44. Zhao H, Lee BT, Fang C. Application of GC-MS in volatile component analysis of botanical tinctures. Anal Chim Acta. 2019;1083:89–99.
45. Li Q, Liu X, Zhou Y, Zhang Q. LC-MS based impurity profiling of phytopharmaceuticals: challenges and perspectives. Chromatographia. 2021;84(5):345–60.
46. Sun Z, Gao H, Wu Y, Song C. Use of cyclodextrin complexes to enhance solubility in elixir formulations. Drug Dev Ind Pharm. 2017;43(6):995–1004.
47. Niazi S. Handbook of Pharmaceutical Manufacturing Formulations: Oral Liquid Products. Vol 1. Boca Raton: CRC Press; 2009.
48. Rowe RC, Sheskey PJ. Handbook of Pharmaceutical Excipients. 6th ed. London: Pharmaceutical Press; 2009.
49. Chein YW, editor. Novel Drug Delivery Systems. 2nd ed. New York: Marcel Dekker; 1992.
50. Florence AT, Attwood D. Physicochemical Principles of Pharmacy. 6th ed. London: Pharmaceutical Press; 2011.
51. Muyumba NW, Moyo M, Moyo B. Quality control of herbal drugs and preparations. Phytochem Anal. 2021;32(4):460–73. doi:10.1002/pca.70000.
52. González-González O, González-González I, González-González M. Drug stability: ICH versus accelerated predictive stability testing. Pharmaceutics. 2022;14(9):1886. doi:10.3390/pharmaceutics14091886.
53. Wang H, Zhang Y, Li Y. Advancing herbal medicine: enhancing product quality and safety. Phytomedicine. 2023;100:154226. doi:10.1016/j.phymed.2022.154226.
54. Pavčnik L, Kocbek P, Kristl J. Accelerated predictive stability testing: A new approach for herbal medicinal products. J Pharm Biomed Anal. 2025;195:113953. doi:10.1016/j.jpba.2020.113953.
55. Sharma B, Singh R, Sharma S. Chromatography and hyphenated techniques in quality control of herbal medicines. Phytochem Anal. 2023;34(1):1–15. doi:10.1002/pca.70000.
56. Devi S, Kumar S, Yadav S. Advancements in quantitative and qualitative methods for herbal drug quality control. Phcog Res. 2025;17(1):1–12. doi:10.4103/0974-8490.303030.
57. Sik B, Kocsis B, Szabó A. Investigation of the long-term stability of various tinctures and herbal extracts. J Pharm Biomed Anal. 2021;195:113953. doi:10.1016/j.jpba.2021.113953.
58. Mutha RE, Kumar S, Singh R. Modern analytical techniques for quality control and chemical identification of phytochemicals. In: Phytochemical Analysis: Techniques and Applications. Wiley; 2025. p. 123–45.
59. Eghbali S, Ghaffari SM, Miri R. An overview of analytical methods employed for quality control of herbal medicines. J Pharm Biomed Anal. 2023;205:114333. doi:10.1016/j.jpba.2022.114333.
60. González-González O, González-González I, González-González M. Drug stability: ICH versus accelerated predictive stability testing. Pharmaceutics. 2022;14(9):1886. doi:10.3390/pharmaceutics14091886.
61. Wang H, Zhang Y, Li Y. Advancing herbal medicine: enhancing product quality and safety. Phytomedicine. 2023;100:154226. doi:10.1016/j.phymed.2022.154226.
62. Pavčnik L, Kocbek P, Kristl J. Accelerated predictive stability testing: A new approach for herbal medicinal products. J Pharm Biomed Anal. 2025;195:113953. doi:10.1016/j.jpba.2020.113953.
63. Sharma B, Singh R, Sharma S. Chromatography and hyphenated techniques in quality control of herbal medicines. Phytochem Anal. 2023;34(1):1–15. doi:10.1002/pca.70000.
64. Devi S, Kumar S, Yadav S. Advancements in quantitative and qualitative methods for herbal drug quality control. Phcog Res. 2025;17(1):1–12. doi:10.4103/0974-8490.303030.
65. Sik B, Kocsis B, Szabó A. Investigation of the long-term stability of various tinctures and herbal extracts. J Pharm Biomed Anal. 2021;195:113953. doi:10.1016/j.jpba.2021.113953.
66. Mutha RE, Kumar S, Singh R. Modern analytical techniques for quality control and chemical identification of phytochemicals. In: Phytochemical Analysis: Techniques and Applications. Wiley; 2025. p. 123–45.
67. Eghbali S, Ghaffari SM, Miri R. An overview of analytical methods employed for quality control of herbal medicines. J Pharm Biomed Anal. 2023;205:114333. doi:10.1016/j.jpba.2022.114333.
68. González-González O, González-González I, González-González M. Drug stability: ICH versus accelerated predictive stability testing. Pharmaceutics. 2022;14(9):1886. doi:10.3390/pharmaceutics14091886.
69. Wang H, Zhang Y, Li Y. Advancing herbal medicine: enhancing product quality and safety. Phytomedicine. 2023;100:154226. doi:10.1016/j.phymed.2022.154226.
70. Pavčnik L, Kocbek P, Kristl J. Accelerated predictive stability testing: A new approach for herbal medicinal products. J Pharm Biomed Anal. 2025;195:113953. doi:10.1016/j.jpba.2020.113953.