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Related Concept Videos

Insulin Formulations: Types and Delivery01:27

Insulin Formulations: Types and Delivery

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Insulin preparations are categorized by their duration of action into short-acting and long-acting types. Two strategies are used to modify insulin's absorption and pharmacokinetic profile: slowing the absorption post-subcutaneous injection, or altering human insulin's amino acid sequence or protein structure. These changes retain the insulin's ability to bind to the insulin receptor, but alter its behavior in solution or after injection.
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Biopharmaceutics and Pharmacokinetics: Overview01:28

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Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
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Drug Delivery: Overview01:16

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The selection of a drug's delivery route depends upon its physicochemical properties, including lipid or water solubility and ionization, as well as the therapeutic requirement, such as immediate or sustained effect. These routes can be divided into three primary categories: enteral, parenteral, and topical.
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Drug Delivery: Miscellaneous Routes01:22

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Drug delivery methods like oral inhalation, nasal sprays, transdermal patches, eye drops, intravitreal injection,  and rectal administration provide localized effects with reduced toxicity.
Oral inhalation and nasal sprays swiftly transfer drugs across the respiratory epithelium's mucosal layer. Inhaled glucocorticoids and bronchodilators directly target lung conditions such as asthma, while fluticasone nasal spray mitigates allergic rhinitis.
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Drug Administration and Therapy Phases: Overview01:26

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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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Insulin: Biosynthesis, Chemistry, and Preparation01:25

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The endoplasmic reticulum (ER) of pancreatic β-cells synthesizes preproinsulin, which consists of a signal peptide, A and B chains, and a C-peptide. Preproinsulin is then cleaved and folded into proinsulin, which translocates to the Golgi apparatus for sorting and packaging into secretory granules. In these granules, enzymatic clipping generates insulin and C-peptide.
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The Quantification of Injectability by Mechanical Testing
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Current State and Opportunities with Long-acting Injectables: Industry Perspectives from the Innovation and Quality

Andrea Bauer1, Philippe Berben2, Sudhir S Chakravarthi3

  • 1Sunovion Pharmaceuticals, Marlborough, MA, 01752, USA.

Pharmaceutical Research
|February 22, 2023
PubMed
Summary

Long-acting injectables (LAIs) offer improved patient adherence and therapeutic outcomes through sustained drug release. This review covers LAI development, manufacturing, characterization, and challenges, including a lack of suitable in vitro models.

Keywords:
drug product developmentformulation developmentlong-acting injectablespre-clinical assessmentsquality attributes

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Biotechnology

Background:

  • Long-acting injectable (LAI) formulations offer advantages over oral drugs, including sustained release, reduced dosing frequency, and improved patient adherence.
  • LAIs represent significant drug product development opportunities in the pharmaceutical industry.

Purpose of the Study:

  • To provide an industry perspective on the development and challenges associated with long-acting injectable formulations.
  • To review various LAI types, manufacturing considerations, and characterization methods.

Main Methods:

  • Review of polymer-based, oil-based, and crystalline drug suspension LAIs.
  • Discussion of manufacturing processes, quality control, API considerations, and biopharmaceutical properties.
  • Exploration of in vitro, in vivo, and in silico characterization approaches for LAIs.

Main Results:

  • LAI development involves complex manufacturing, quality control, and selection based on API and clinical needs.
  • Characterization requires a combination of in vitro, in vivo, and in silico methods.
  • A significant challenge is the current lack of compendial and biorelevant in vitro models for LAI evaluation.

Conclusions:

  • LAI technology offers substantial therapeutic benefits but faces development hurdles.
  • Improved in vitro models are crucial for efficient LAI product development and regulatory approval.