Introduction
Coronary heart disease (CHD) remains one of the leading causes of death worldwide, posing a significant public health challenge. The accumulation of lipids in the blood vessels can lead to ischemic heart disorders and angina pectoris, which requires efficient management and treatment. In this context, a groundbreaking study has been published in the Saudi Pharmaceutical Journal detailing the development of a novel medication delivery method – sublingual tablets containing a combination of Atorvastatin calcium (ATOR) and Trimetazidine HCl (TMZ).
DOI: 10.1016/j.jsps.2019.02.001
The study titled “Novel Sublingual Tablets of Atorvastatin Calcium/Trimetazidine Hydrochloride Combination; HPTLC Quantification, In Vitro” sheds light on the formulation and efficacy of these tablets. Conducted by Atia Noha et al., the research underlines a new strategy in the management of CHD with promising implications for patient compliance and instant action of the delivered drugs.
Groundbreaking Research on Sublingual Tablets
Atorvastatin calcium, a water-insoluble molecule, is known for its lipid-lowering effects, and Trimetazidine HCl helps reduce oxygen consumption in the heart muscle. Combining these two drugs into a single dosage form can streamline the medication regimen for CHD patients. However, Atorvastatin’s water-insolubility poses challenges for effective drug delivery and absorption.
The research by Atia Noha N et al. overcomes these challenges by enhancing the dissolution rate of Atorvastatin using complexation with sulfobutyl ether-β-cyclodextrin (SBE-β-CD) and incorporating soluplus, a polymeric solubilizer. The solubilized active pharmaceutical ingredients (APIs) were manufactured into sublingual tablets via a direct compression technique and subsequently assessed for their tablet characteristics.
A noteworthy breakthrough is the authors’ development of a validated High Performance Thin Layer Chromatography (HPTLC) method for the simultaneous determination of both drugs in pure form and in tablet form. The HPTLC technique showcased limits of detection (LODs) of 0.056 and 0.013 μg/band and limits of quantification (LOQs) of 0.17, 0.040 μg/band for TMZ and ATOR, respectively. These findings confirmed that the HPTLC method was linear, accurate, precise, and robust.
Enhanced Release Profiles and Patient Compliance
Sublingual administration of medication offers several advantages over traditional oral administration, such as bypassing the liver’s first-pass effect, resulting in faster onset of action and increased bioavailability. The researchers discovered that the optimal formulation, containing a mixture of the superdisintegrants Ac-Di-Sol and crospovidone (4.8% w/w each), presented the shortest disintegration time of 65 seconds and improved the release profiles of both ATOR and TMZ.
The significance of this development lies not only in the efficacy of the medication but also in its potential for improved patient compliance. Sublingual tablets are easier to administer and can be particularly beneficial for patients who have difficulty swallowing or require rapid onset of symptom relief.
Implications for Future Treatment Protocols
The results of this study suggest that this novel formulation of sublingual tablets could provide a more efficient treatment option for patients with coronary heart disease. Patients could benefit from the combination therapy, which could offer added convenience and potentially better health outcomes due to improved adherence and rapid relief from anginal symptoms.
References
1. Atia Noha N et al. Novel Sublingual Tablets of Atorvastatin Calcium/Trimetazidine Hydrochloride Combination; HPTLC Quantification, In Vitro. Saudi Pharm J. 2019;27(4):540-549. doi: 10.1016/j.jsps.2019.02.001. [PMC6488851]
2. Aboutaleb A.E., Abdel-Rahman S.I., Ahmed M.O., Younis M.A. Design and evaluation of domperidone sublingual tablets. Int. J. Pharm. Pharm. Sci. 2016;8(6):195–201.
3. Ahjel S.W., Lupuleasa D. Enhancement of solubility and dissolution rate of different forms of atorvastatin calcium in direct compression tablet formulas. Farmacia. 2009;57(3):290–300.
4. Al-ghamdi A.F. High sensitivity determination of atorvastatin calcium in pharmaceuticals and biological fluids using adsorptive anodic stripping voltammetry onto the surface of ultra-trace graphite electrode. Curr. Anal. Chem. 2018;14(2):92–100.
5. AlShehri M.M. Validated capillary electrophoresis method for simultaneous determination of ezetimibe and atorvastatin in pharmaceutical formulations. Saudi Pharm. J. 2012;20(2):143–148. PMC3745071. doi: 10.1016/j.jsps.2011.11.003.
Keywords
1. Sublingual tablets
2. Atorvastatin calcium
3. Trimetazidine hydrochloride
4. CHD treatment
5. Novel drug delivery
Conclusion
The research outlined in the Saudi Pharmaceutical Journal is set to revolutionize the approach to managing coronary heart disease. The novel sublingual tablets containing a combination of Atorvastatin calcium and Trimetazidine hydrochloride have showcased potential as an efficient, fast-acting, and patient-friendly option. This therapy may lead to improved adherence and better patient outcomes, highlighting a significant step forward in CHD treatment.
