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Atorvastatin Tablet Image: Insights from Recent Research
Development of Lyophilized Dry Emulsion Tablets for Atorvastatin
Recent advancements in pharmaceutical formulations have led to the development of lyophilized dry emulsion tablets (LDET) for atorvastatin calcium (ATV). These tablets are designed to enhance the drug's in-vitro dissolution and in-vivo performance, addressing the issue of poor bioavailability. The preparation involves freeze-drying oil-in-water emulsions of ATV, using a matrix former solution (alginate or gelatin), a sugar alcohol (mannitol), and a collapse protectant (glycine)1. The resulting tablets exhibit a porous, non-collapsible structure with complete loss of ATV crystallinity, as confirmed by SEM images. This formulation significantly improves the dissolution rate of ATV compared to the plain drug, making it a promising dosage form for hyperlipidemia treatment1.
Identification and Quantitative Determination of Atorvastatin Polymorphs
Atorvastatin calcium (ATC) exists in multiple polymorphic forms, which can complicate its identification and quantification in tablet formulations. Techniques such as FT-Raman spectroscopy, IR spectroscopy, and X-ray powder diffraction (XRD) have been employed to address this challenge. Among these, Raman spectroscopy has shown a lower detection limit and higher accuracy, with a calibration model yielding an error of just 1.25% when applied to commercial ATC tablets2. This method is particularly useful for distinguishing between different polymorphs and ensuring the quality of atorvastatin tablets.
Effects of Atorvastatin on Carotid Plaque Inflammation
The ATHEROMA study investigated the impact of different doses of atorvastatin on carotid plaque inflammation using ultrasmall superparamagnetic iron oxide (USPIO)-enhanced MRI. Patients with significant carotid stenosis were treated with either 10 mg or 80 mg of atorvastatin daily. The study found that the higher dose (80 mg) significantly reduced USPIO-defined inflammation within 12 weeks, while the lower dose did not show a similar effect. This reduction in inflammation was accompanied by a decrease in total cholesterol and LDL cholesterol levels, highlighting the anti-inflammatory benefits of high-dose atorvastatin therapy3.
Combination Therapy: Amlodipine and Atorvastatin
Amlodipine/atorvastatin (Caduet®) is a fixed-dose combination tablet that combines the benefits of a calcium channel antagonist and an HMG-CoA reductase inhibitor. Clinical trials have demonstrated that this combination effectively reduces both systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-C) levels. The single-tablet formulation improves patient adherence compared to coadministration of separate tablets, making it a convenient option for managing hypertension and dyslipidemia. Additionally, this combination has been shown to prevent cardiovascular events in patients at risk of cardiovascular disease4.
Quality Concerns of Atorvastatin Tablets Available Online
A preliminary investigation into the quality of atorvastatin calcium tablets purchased from Japanese-language websites revealed significant concerns. Using Raman spectroscopy and X-ray computed tomography (CT), researchers identified substandard medicines with slower drug release profiles. One product, in particular, showed massive agglomerations that hindered tablet disintegration. This study underscores the risks associated with purchasing prescription drugs online, where quality assurance is often lacking5.
Conclusion
The research on atorvastatin tablets highlights significant advancements in formulation techniques, quality control, and therapeutic efficacy. Lyophilized dry emulsion tablets offer improved bioavailability, while advanced spectroscopic methods ensure accurate identification of polymorphs. High-dose atorvastatin effectively reduces carotid plaque inflammation, and combination therapy with amlodipine enhances patient adherence and cardiovascular outcomes. However, the prevalence of substandard medicines online remains a critical issue, emphasizing the need for stringent quality control measures.
Sources and full results
Most relevant research papers on this topic
Experimentally designed lyophilized dry emulsion tablets for enhancing the antihyperlipidemic activity of atorvastatin calcium: Preparation, in‐vitro evaluation and in‐vivo assessment
Lyophilized dry emulsion tablets, prepared using the dry emulsion technique, enhance the bioavailability and in-vivo performance of atorvastatin calcium, making them a promising and effective treatment for hyperlipidemia.
In Vitro StudyIdentification and quantitative determination of atorvastatin calcium polymorph in tablets using FT-Raman spectroscopy.
FT-Raman spectroscopy effectively identifies and quantifies atorvastatin calcium polymorphs in tablets, with a 1.25% error rate for commercial 40mg strength tablets.
The ATHEROMA (Atorvastatin Therapy: Effects on Reduction of Macrophage Activity) Study. Evaluation using ultrasmall superparamagnetic iron oxide-enhanced magnetic resonance imaging in carotid disease.
Atorvastatin 80 mg daily for 12 weeks significantly reduces carotid plaque inflammation, with USPIO-enhanced MRI potentially being a useful imaging biomarker for atherosclerotic patients.
RCT
Highly CitedPharmaceutical evaluation of atorvastatin calcium tablets available on the Internet: A preliminary investigation of substandard medicines in Japan
Internet distribution of unqualified prescription drugs like atorvastatin calcium tablets is common, with some showing slower drug release due to massive agglomerations.
Bilayer tablets of atorvastatin calcium and nicotinic acid: formulation and evaluation.
Bilayer tablets containing atorvastatin calcium and nicotinic acid show potential as a viable dosage form for delivering these drugs.
In Vitro StudyHighly CitedPharmacokinetics and bioequivalence evaluation of two different atorvastatin calcium 10-mg tablets: A single-dose, randomized-sequence, open-label, two-period crossover study in healthy fasted Chinese adult males.
The test and reference formulations of atorvastatin calcium 10-mg tablets showed pharmacokinetic and bioequivalence in healthy fasted Chinese male volunteers.
RCTNovel sublingual tablets of Atorvastatin calcium/Trimetazidine hydrochloride combination; HPTLC quantification, in vitro formulation and characterization
Sublingual tablets combining Atorvastatin calcium and Trimetazidine hydrochloride show promising potential for treating coronary heart disease with instant action and improved patient compliance.
In Vitro StudyAtorvastatin: safety and tolerability
Atorvastatin is generally well tolerated across its therapeutic dosage range, with rare adverse events (liver function abnormalities and muscle-related side effects) occurring in specific populations.
Systematic Review