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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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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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Bioequivalence: Overview01:16

Bioequivalence: Overview

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Bioequivalence studies: Biowaivers01:13

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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Dosage Regimen: Multiple Oral Dosage01:25

Dosage Regimen: Multiple Oral Dosage

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Understanding how a drug's concentration fluctuates within the body over time is crucial in pharmacokinetics, particularly with multiple oral doses. A graphical representation of multiple oral dosages provides insight into these dynamics. Typical accumulation curves of a drug's concentration in the body reveal a sawtooth pattern, indicating periodic peaks and troughs correlating with each dose administration and the drug's subsequent elimination.The plasma concentration at any time during an...
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Related Experiment Video

Updated: Nov 3, 2025

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Topical sirolimus: Difference between compounded preparations and commercial oral solution.

Lars Brichta1, James G Carver2, Cynthia Marie Carver DeKlotz3,4

  • 1Chemistry Rx Compounding and Specialty Pharmacy, Folcroft, PA, USA.

Pediatric Dermatology
|June 1, 2021
PubMed
Summary

Topical sirolimus is used for skin conditions, but no FDA-approved cream exists. This article compares compounded topical sirolimus with the oral solution to guide provider choices.

Keywords:
angiofibromacompoundingsirolimustopicalvascular anomaly

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Area of Science:

  • Dermatology
  • Pharmaceutical Sciences

Background:

  • Topical sirolimus is increasingly used for various dermatologic conditions.
  • Currently, no FDA-approved topical formulation of sirolimus is commercially available.
  • Compounded topical preparations and the oral solution are commonly used off-label.

Purpose of the Study:

  • To compare the pharmaceutical and clinical differences between compounded topical sirolimus and the commercial oral solution.
  • To provide guidance for healthcare providers considering topical sirolimus therapy.

Main Methods:

  • Review of existing literature and pharmaceutical data.
  • Analysis of formulation differences and clinical application guidelines.

Main Results:

  • Significant pharmaceutical differences exist between compounded topical formulations and the oral solution.
  • Clinical considerations vary based on the preparation used.

Conclusions:

  • Understanding these differences is crucial for optimizing topical sirolimus treatment.
  • This comparison aims to support informed clinical decision-making for dermatologists.