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Related Concept Videos

Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

205
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: 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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Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

189
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...
189
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

567
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...
567

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GM-611 (Chugai Pharmaceutical).

T L Peeters1

  • 1Gasthuisberg ON, Gut Hormone Laboratory, Leuven, Belgium. theo.peeters@med.kuleuven.ac.be

Current Opinion in Investigational Drugs (London, England : 2000)
|September 22, 2001
PubMed
Summary
This summary is machine-generated.

GM-611, a motilin receptor agonist, shows promise for treating gastric motility disorders. This erythromycin derivative stimulates gastrointestinal peristalsis and is currently in Phase II trials for reflux esophagitis.

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Area of Science:

  • Gastroenterology
  • Pharmacology

Background:

  • Gastric motility disorders affect millions globally.
  • Current treatments have limitations, necessitating novel therapeutic approaches.
  • Diabetic gastroparesis and reflux esophagitis represent significant unmet medical needs.

Purpose of the Study:

  • To investigate the therapeutic potential of GM-611, an erythromycin derivative, for gastrointestinal motility disorders.
  • To elucidate the mechanism of action of GM-611.
  • To assess the efficacy of GM-611 in clinical trials.

Main Methods:

  • GM-611 was investigated as a motilin receptor agonist.
  • Preclinical studies involved assessing effects on rabbit duodenal smooth muscle depolarization.
  • Clinical trials (Phase II) were conducted for reflux esophagitis in the US.

Main Results:

  • GM-611 stimulates and promotes peristalsis in the stomach and gastrointestinal tract.
  • The drug induced a dose-dependent sustained depolarization of rabbit duodenal smooth muscle.
  • Activation of monovalent cation-selective channels was implicated in the observed depolarization.

Conclusions:

  • GM-611 represents a novel therapeutic agent for gastric motility disorders.
  • Its mechanism involves direct stimulation of gastrointestinal motility.
  • Positive clinical trial outcomes could lead to significant market potential.