DISSOLUTION PROFILE OF AMBROXOL HCl TABLET WITH ADDITIONAL VARIATIONS OF LUDIPRESS® AND LACTOSE USING THE DIRECT PRESS METHOD

  • RESMI MUSTARICHIE Faculty of Pharmacy, Universitas Padjadjaran, Hegarmanah, Jatinangor, Jawa Barat 45363, Indonesia
  • DOLIH GOZALI Faculty of Pharmacy, Universitas Padjadjaran, Hegarmanah, Jatinangor, Jawa Barat 45363, Indonesia
  • DRADJAD PRIAMBODO Faculty of Pharmacy, Universitas Padjadjaran, Hegarmanah, Jatinangor, Jawa Barat 45363, Indonesia

Abstract

Objective: The drug will provide a therapeutic effect when dissolved so that it is easily absorbed. The process of dissolving drugs is called dissolution. Additional substances contained in pharmaceutical preparations, one of which serves to accelerate the solubility of active substances. The aim of this study was to obtain a comparative composition of Ludipress® and lactose additives suitable for producing ambroxol HCl tablets that met the ambroxol acceleration ambroxol in the body.


Methods: Ambroxol HCl tablets were made by direct pressing method. For research purposes, 4 formulas with variations of Ludipress® and Lactose were designed. The tablet was then evaluated, which includes uniformity in weight, diameter, thickness, hardness, friability, disintegration time, and dissolution. Data obtained in the analysis using the perfect random block design method (DBAS) with α = 0.05 where blocks and groups were used.


Results: From the results of the Mass Printing Evaluation of Tablets, it was found that the four formulas that were designed met the resting angle, flow rate, real density, compressed density, and compressibility met existing requirements. The results of evaluation tablets, which included uniformity of weight, uniformity of size, hardness, friability, disintegration time, and dissolution test, were found that only F1 formula did not meet uniformity requirements. All four formulas meet the Indonesian pharmacopeia requirements for time of violence, fragility and disintegration. The dissolution test results showed that in the 45-minute test each percent dissolved concentration of the active substance for F1, F2, F3, and F4 was 58.77974, 66.91104, 80.09946, and 64.02293 suggesting only the F3 formula fulfilled the dissolution requirements according to European Pharmacopoeia which stated that the concentration of dissolved active tablets should not be less than 75% during the 45-minute test.


Conclusion: The formula that met the solubility requirements consisted of an additional 69% Ludipress® and 10% lactose with a solubility value of 80.09%.

Keywords: Dissolution profile, Ambroxol HCl tablets, Direct press, Ludipress®, Lactose

References

1. Mark D, Zeitler JA. A review of disintegration mechanisms and measurement techniques. Pharm Res 2017;34:890–917.
2. Khadka P, Ro J, Kim H, Kim I, Kim JT, Kim H, et al. Pharmaceutical particle technologies: an approach to improve drug solubility, dissolution, and bioavailability. Asian J Pharm Sci 2014;9:304-16.
3. Jaysukh J, Hirani JJ, Rathod DA, Vadalia KR. Orally disintegrating tablets: a review. Trop J Pharm Res 2009;8:161-72.
4. Sharma D, Singh M, Kumar D, Singh G. Simultaneous estimation of ambroxol hydrochloride and cetirizine hydrochloride in pharmaceutical tablet dosage form by simultaneous equation spectrophotometric method: a quality control tool for dissolution studies. ISRN Anal Chem 2014:1-6. Doi:10.1155/2014/236570
5. Basak SC, Mani KPL, Reddy BMJ. Formulation and release behavior of sustained-release ambroxol hydrochloride HPMC matrix tablet. Indian J Pharm Sci 2006;68:594-8.
6. Hull University Teaching Hospitals NHS Trust. A Study of the Effect of 20 mg Ambroxol Hydrochloride on Acute Cough. Available from: https://clinicaltrials. gov/ct2/show/ NCT03415269. [Last accessed on 05 Jan 2020]
7. Sandhya KM, Shanmugam S, Vetrichelvan T. Design and development of ambroxol hydrochloride sustained release matrix tablets. Int J Pharm Pharm Sci 2011;13 Suppl 3:200­3.
8. Abd Elbary A, Haider M, Sayed S. In vitro characterization and release study of ambroxol hydrochloride matrix tablets prepared by direct compression. Pharm Dev Technol 2012;17:562-73.
9. Rangnath RA, Kumar JH, Namdeorao GK. Development and validation for UV Spectrometric estimation of ambroxol hydrochloride in bulk and tablet dosage form using the area under the curve method. Int Res J Pharm 2014;5:580-3.
10. Akhter DT, Uddin R, Sutradhar KB, Rana S. In vitro release kinetic study of ambroxol hydrochloride sustained release matrix tablets using hydrophilic and hydrophobic polymers. J Chem Pharm Res 2012;4:1573-9.
11. Hang TJ, Zhang M, Song M, Shen JP, Zhang YD. Simultaneous determination and pharmacokinetic study of roxithromycin and ambroxol hydrochloride in human plasma by LC-MS/MS. Clin Chim Acta 2007;382:20-4.
12. Sumithra S, Shanmugasundaram P, Ravichandiran V. Qality by design-based optimization and validation of new reverse phase-high performance liquid chromatography method for simultaneous estimation of levofloxacin hemihydrate and ambroxol hydrochloride in bulk and its pharmaceutical dosage form. Asian J Pharm Clin Res 2016;9 Suppl 3:190-6.
13. Potawale RS, Gilhotra RM, Gabhe SY. Liquid chromatography-tandem mass spectrometry method development and validation for the simultaneous analysis of paracetamol, guaifenesin, phenylephrine hydrochloride, chlorpheniramine maleate, and ambroxol hydrochloride in the tablet dosage form. Asian J Pharm Clin Res 2018;11:375-82.
14. Brown CK, Friedel HD, Barker AR, Buhse LF, Keitel S, Cecil TL, et. al. Meeting report: FIP/AAPS joint workshop report: dissolution/in vitro release testing of novel/special dosage forms. AAPSPharmSciTech 2011;12:782-94.
15. BASF. Technical Information. Germany: BASF Chemical Industry; 2003.
16. Heinz R, Karbstein HP, Wolf H, End L. Formulation and development of tablets based on ludipress and scale-up from laboratory to production scale. Drug Dev Ind Pharm 2000;26:513-21.
17. Malerba M, Ragnoli B. Ambroxol in the 21st century: a pharmacological and clinical update. Expert Opin Drug Metab Toxicol 2008;4:1119–29.
18. McNeill A, Magalhaes J, Shen C, Chau KY, Hughes D, Mehta A, et al. Ambroxol improves lysosomal biochemistry in glucocerebrosidase mutation-linked Parkinson disease cells. Brain 2014;137:1481–95.
19. Ambroxol Hydrochloride. Available from: https:// www.drugs.com/ambroxol.html [Last accessed on 05 Jan 2020]
20. Departemen Kesehatan Republik Indonesia. Farmakope Indonesia. Edisi III. Jakarta: Departemen Kesehatan Republik Indonesia; 1979
21. Departemen Kesehatan Republik Indonesia. Farmakope Indonesia. Edisi IV. Jakarta: Departemen Kesehatan Republik Indonesia; 1995.
22. Beringer P. Remington, the science and practice of pharmacy. 21st edition. Philadelphia: Lippincott Williams and Wilkins; 2005. p. 889-91.
23. Gibson M. Editors. Pharmaceutical pre-formulation and formulation. Florida: CRC Press; 2004. p. 417-8.
24. Aulton ME. Pharmaceutics: the science of dosage form design. New York: Longman Group Churchill Livingstone; 2002. p. 02, 124, 246-48.
25. United States Pharmacopeial Convention. The United States Pharmacopeia 30. Twinbrook Parkway MD: United States Pharmacopeial Convention, Inc; 2007.
26. European Pharmacopoeia Commission. European Pharmacopoeia 6. Council of Europe; 2007.
27. Trochim WMK. Research Methods Knowledge Base. Available from: https://socialresearchmethods.net/kb/randomized-block-designs/. [Last accessed on 06 Jan 2020]
28. Grant T. The randomized complete block design (RCBD). Available from: https://pbgworks.org/sites/pbgworks.org/files/RandomizedCompleteBlockDesignTutorial.pdf. [Last accessed on 06 Jan 2020]
29. Rowe RC, Sheskey PJ, Cook WG, Quinn ME. Editors. Handbook of Pharmaceutical Excipients. 7th Edition. Pharmaceutical Development and Technology, UK: The Pharmaceutical Press; 2013;18:2, 544.
30. Mustarichie R, Priambodo D. Tablet formulation from meniran (Phyllanthus niruri L.) extract with direct compression method. Int J Appl Pharm 2018;10:98-102.
31. Li Q, Guan X, Cui M, Zhu Z, Chen K, Wen H, et al. Preparation and investigation of novel gastro-floating tablets with 3D extrusion-based printing. Int J Pharm 2018;535:325-32.
32. The United States Pharmacopeia. The National Formulary 23. 29th Edition. Vol. I. Washington DC: United States Pharmacopeia Convention Inc; 2006.
Statistics
72 Views | 53 Downloads
Citatons
How to Cite
MUSTARICHIE, R., GOZALI, D., & PRIAMBODO, D. (2020). DISSOLUTION PROFILE OF AMBROXOL HCl TABLET WITH ADDITIONAL VARIATIONS OF LUDIPRESS® AND LACTOSE USING THE DIRECT PRESS METHOD. International Journal of Applied Pharmaceutics, 12(3), 62-66. https://doi.org/10.22159/ijap.2020v12i3.37001
Section
Original Article(s)