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Related Concept Videos

Production of Pharmaceuticals01:30

Production of Pharmaceuticals

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Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under...
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In Vitro Drug Dissolution: Compendial Testing Models II01:09

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Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
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In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
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Modified-Release Drug Delivery Systems: Classification01:23

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Modified-release drug delivery systems improve drug efficacy and minimize side effects by controlling the rate and location of drug release. These systems fall into three categories: rate-programmed, stimuli-activated, and site-targeted.Rate-programmed systems release drugs at a predetermined rate, maintaining consistent therapeutic levels and reducing fluctuations that could lead to toxicity or subtherapeutic effects. These systems use polymeric matrices, reservoir-based designs, or osmotic...
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Modified-Release Drug Delivery Systems: Overview01:19

Modified-Release Drug Delivery Systems: Overview

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Modified-release dosage forms are designed to address the limitations of drugs with short biological half-lives. These forms maintain stable therapeutic drug concentrations over extended periods, reducing the need for frequent dosing. A consistent drug level helps minimize peak-trough fluctuations, which can reduce adverse effects, lower the risk of drug resistance, and improve overall treatment effectiveness.One common type of modified-release form is the extended-release (ER) formulation. ER...
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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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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Preparation of Prokaryotic and Eukaryotic Organisms Using Chemical Drying for Morphological Analysis in Scanning Electron Microscopy SEM
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Next generation drying technologies for pharmaceutical applications.

Robert H Walters1, Bakul Bhatnagar1, Serguei Tchessalov1

  • 1Pfizer, Pharmaceutical R&D - BioTherapeutics Pharmaceutical Sciences, Andover, Massachusetts 01810.

Journal of Pharmaceutical Sciences
|June 12, 2014
PubMed
Summary
This summary is machine-generated.

Freeze-drying (lyophilization) is common for biotherapeutics but has drawbacks. This review explores alternative drying methods like spray drying for improved biopharmaceutical product stability.

Keywords:
dehydrationdryingfoam dryingfreeze-dryinghybrid dryingmicrowaveprocessingproteinsspray dryingsupercritical fluids

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Area of Science:

  • Biopharmaceutical science
  • Chemical engineering
  • Materials science

Background:

  • Drying is crucial for biotherapeutic product stability.
  • Freeze-drying (lyophilization) is the predominant method, but has significant limitations.
  • Limitations include long process times, low energy efficiency, high costs, and product sensitivity to stress.

Purpose of the Study:

  • To review and evaluate alternative drying technologies for biotherapeutics.
  • To compare these methods against traditional freeze-drying.
  • To assess the feasibility of non-traditional drying methods for biopharmaceutical applications.

Main Methods:

  • Review of alternative drying technologies: spray drying, convective drying, vacuum drying, microwave drying, and combined methods.
  • Comparison of alternative methods to freeze-drying, focusing on advantages and disadvantages.
  • Evaluation of the potential application of each technology for biotherapeutic drying.

Main Results:

  • Several alternative drying methods show promise for biotherapeutic processing.
  • Some technologies are already in use, while others are in early feasibility stages.
  • Each method presents unique benefits and challenges compared to lyophilization.

Conclusions:

  • Alternative drying methods offer potential solutions to the limitations of freeze-drying for biotherapeutics.
  • Further research and development are needed to fully implement these next-generation drying technologies.
  • Optimizing these methods could lead to more efficient, cost-effective, and robust biopharmaceutical manufacturing.