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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

248
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,...
248
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

190
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.
190
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

179
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...
179
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

412
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...
412
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

178
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...
178
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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

160
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,...
160

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Pharmaceutical Approval Update.

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    P & T : a Peer-Reviewed Journal for Formulary Management
    |June 5, 2019
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    Summary
    This summary is machine-generated.

    New treatments offer hope for sleep disorders and neurological conditions. Sunosi, Zulresso, and Mayzent address excessive sleepiness, postpartum depression, and multiple sclerosis, respectively, improving patient outcomes.

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    Area of Science:

    • Pharmacology and Therapeutics
    • Neurology
    • Psychiatry

    Background:

    • Excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea presents significant challenges.
    • Postpartum depression affects a considerable number of adult women, requiring effective treatment options.
    • Relapsing forms of multiple sclerosis (MS) necessitate disease-modifying therapies to manage neurological disability.

    Purpose of the Study:

    • To review the efficacy and safety of novel pharmaceutical agents for specific medical conditions.
    • To highlight advancements in the treatment of sleep disorders, mood disorders, and autoimmune neurological diseases.

    Main Methods:

    • Review of clinical trial data and regulatory submissions for new drug approvals.
    • Analysis of pharmacological mechanisms and therapeutic applications of the studied medications.

    Main Results:

    • Sunosi (solriamfetol) demonstrated efficacy in improving wakefulness in patients with narcolepsy or obstructive sleep apnea.
    • Zulresso (brexanolone) injection showed effectiveness in treating adults with postpartum depression.
    • Mayzent (siponimod) tablets proved beneficial for adults with relapsing forms of MS, impacting disease progression.

    Conclusions:

    • These new medications represent significant therapeutic advancements for patients with narcolepsy, obstructive sleep apnea, postpartum depression, and multiple sclerosis.
    • The availability of these treatments expands therapeutic options and addresses unmet medical needs in neurology and psychiatry.