Amlodipine dosage forms
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Amlodipine Dosage Forms: Solid and Liquid Formulations
Solid Dosage Forms of Amlodipine: Tablets and Fixed-Dose Combinations
Amlodipine is most commonly available as a solid oral dosage form, particularly as tablets. These tablets are often formulated as amlodipine besylate, which is a salt form that enhances stability and absorption. Standard tablet strengths include 2.5 mg, 5 mg, and 10 mg of amlodipine, either as a single agent or in combination with other antihypertensive drugs such as valsartan, hydrochlorothiazide, spironolactone, enalapril, bisoprolol, perindopril, and lisinopril. These combinations are available as monolayer or bilayer tablets, allowing for the separation of active ingredients within a single tablet for improved stability and controlled release 1256+3 MORE.
Fixed-dose combination (FDC) tablets are widely used for the management of hypertension and related conditions. For example, amlodipine is combined with valsartan and/or hydrochlorothiazide in various strengths, such as 5/80 mg, 10/160 mg, and other ratios, to provide comprehensive blood pressure control. Similarly, combinations with atorvastatin are available for patients with both hypertension and hypercholesterolemia, typically in strengths like 5 mg amlodipine with 10 mg or 20 mg atorvastatin 1256+1 MORE.
Liquid Dosage Forms: Suspensions for Special Populations
For patients who have difficulty swallowing tablets, such as children or the elderly, amlodipine can be prepared as a liquid suspension. These extemporaneously prepared suspensions are typically made using commercially available tablets and suspending agents like methylcellulose or OraPlus/OraSweet. A common concentration is 1 mg/mL. These liquid forms have been shown to be stable for up to 91 days when refrigerated and for 56 days at room temperature, making them suitable for accurate dosing in pediatric and geriatric populations .
Analytical Methods for Quality Control of Dosage Forms
Various analytical techniques, including high-performance liquid chromatography (HPLC) and spectrophotometry, are used to ensure the quality and consistency of amlodipine in both single and combination dosage forms. These methods are validated for accuracy, precision, and specificity, and are essential for routine quality control and stability testing of amlodipine products 4578+1 MORE.
Conclusion
Amlodipine is available in multiple dosage forms to meet the needs of diverse patient populations. The most common forms are solid oral tablets, including both single-agent and fixed-dose combination products with other antihypertensive or lipid-lowering agents. For patients unable to swallow tablets, stable liquid suspensions can be prepared. These dosage forms are supported by validated analytical methods to ensure their safety, efficacy, and quality 1234+6 MORE.
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Most relevant research papers on this topic
Stability of amlodipine besylate in two liquid dosage forms.
Amlodipine besylate is stable in two liquid dosage forms, methylcellulose in syrup and OraPlus/OraSweet, for 91 days at 4°C and 56 days at 25°C, making them suitable for pediatric and elderly patients unable to swallow tablets.
Efficient validated method of HPLC to determine amlodipine in combinated dosage form containing amlodipine, enalapril and bisoprolol and in vitro dissolution studies with in vitro/ in vivo correlation
The developed HPLC method effectively determines amlodipine in combined dosage forms and in vitro dissolution studies, allowing for comparative studies and FDA-compliant dissolution studies.
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