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Related Concept Videos

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

423
Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
423
Drug Accumulation During Multiple Dosing: Repetitive IV Injections01:21

Drug Accumulation During Multiple Dosing: Repetitive IV Injections

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Calculating drug dosage and accumulation in multiple-dose regimens is crucial for achieving therapeutic efficacy while avoiding toxicity. This involves determining the plasma drug concentrations over time to optimize dosing schedules. The principle of superposition is fundamental in this process, allowing for the prediction of drug concentration in plasma following multiple doses based on single-dose data.The principle of superposition asserts that the plasma concentration-time curves from...
34
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

15
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
15
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
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Antiplatelet Drugs: Prostaglandin Synthesis, P2Y12 and Glycoprotein IIb/IIIa Inhibitors01:20

Antiplatelet Drugs: Prostaglandin Synthesis, P2Y12 and Glycoprotein IIb/IIIa Inhibitors

735
Antiplatelet drugs emerge as frontline defenders against the insidious threat of thromboembolic diseases, where abnormal clots obstruct vital blood vessels. These drugs stand as bulwarks, inhibiting platelet aggregation and clot formation, thereby mitigating the risk of life-threatening conditions like myocardial infarction, coronary artery disease, and thrombotic strokes.
Prostaglandin synthesis inhibitors, exemplified by the widely known aspirin, wield their power by irreversibly acetylating...
735

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Related Experiment Video

Updated: Oct 13, 2025

Inducing Polyp Bail-out in Coral Colonies to Obtain Individualized Micropropagates for Laboratory Experimental Use
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[Two decades later, the polypill revisited].

Gilles Bouvenot1

  • 1Professeur emerite a la faculte de medecine de Marseille. Membre de l'Academie nationale de medecine.

La Revue Du Praticien
|November 18, 2021
PubMed
Summary

Polypill effectiveness remains debated after 20 years, with concerns about long-term side effects and variable composition. Regulatory approval and over-the-counter availability face significant challenges due to safety and efficacy questions.

Area of Science:

  • Cardiovascular Medicine
  • Pharmacology
  • Public Health

Background:

  • The Polypill, a combination drug for cardiovascular disease prevention, was introduced with high expectations.
  • Two decades later, its widespread adoption and clinical impact remain subjects of ongoing evaluation.

Purpose of the Study:

  • To critically assess the fulfillment of the Polypill's initial promises.
  • To review the evidence regarding its long-term effectiveness and safety profile.
  • To examine challenges in regulatory approval and potential for over-the-counter status.

Main Methods:

  • Review of existing clinical trial data and post-marketing surveillance studies.
  • Analysis of the pharmacological rationale and composition variability of different Polypill formulations.
Keywords:
Cardiovascular riskPrimary Prevention

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  • Evaluation of regulatory requirements for combination drug approval.

    • Main Results:

    • Polypill effectiveness is still debated, with insufficient long-term data in healthy populations.
    • Concerns persist regarding long-term adverse effects, especially from aspirin, in individuals without established cardiovascular disease.
    • Variable Polypill compositions raise questions about optimal formulation and component relevance.
    • Regulatory hurdles exist, requiring demonstration of individual component benefit and contribution.

    Conclusions:

    • The Polypill's advantages do not clearly outweigh its disadvantages, particularly for primary prevention in healthy individuals.
    • Its validation by regulatory authorities is challenging given current evidence.
    • Reclassifying the Polypill as an over-the-counter drug is premature and potentially unsafe due to its target population and safety profile.