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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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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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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
474
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

181
Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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

163
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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Pharmaceutical Approval Update.

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    P & T : a Peer-Reviewed Journal for Formulary Management
    |April 2, 2019
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    Summary
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    Three medications, Motegrity (prucalopride), Aemcolo (rifamycin), and Dextenza (dexamethasone ophthalmic insert), are highlighted for their efficacy in treating chronic idiopathic constipation, travelers

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    Area of Science:

    • Gastroenterology and Ophthalmology
    • Pharmacology and Therapeutics

    Background:

    • Chronic idiopathic constipation (CIC) significantly impacts quality of life.
    • Travelers' diarrhea poses a common health risk for international travelers.
    • Post-operative ocular pain requires effective management following ophthalmic surgery.

    Purpose of the Study:

    • To review the efficacy of Motegrity (prucalopride) in managing chronic idiopathic constipation.
    • To assess the effectiveness of Aemcolo (rifamycin) for the treatment of travelers' diarrhea.
    • To evaluate the use of Dextenza (dexamethasone ophthalmic insert) for post-ophthalmic surgery ocular pain.

    Main Methods:

    • Review of clinical trial data and prescribing information for prucalopride.
    • Analysis of studies evaluating rifamycin efficacy in infectious diarrhea.
    • Examination of clinical outcomes associated with dexamethasone ophthalmic inserts.

    Main Results:

    • Prucalopride demonstrates significant improvements in bowel movement frequency and constipation symptoms.
    • Rifamycin shows rapid and effective resolution of symptoms associated with travelers' diarrhea.
    • Dexamethasone ophthalmic inserts provide sustained relief from ocular pain post-surgery.

    Conclusions:

    • Motegrity (prucalopride) is an effective treatment option for chronic idiopathic constipation.
    • Aemcolo (rifamycin) offers a targeted approach to treating travelers' diarrhea.
    • Dextenza provides a valuable therapeutic option for managing post-operative ocular pain.