Formulation of Small Molecule Injectable Drug Products

Event Information
Product Format
Prerecorded Event
Lori Herz, Ph.D.
60 Minutes
Product Description

Requirements and Challenges of Formulating Small Molecule Injectable Drug Products

In healthcare, injectable drug products plays a crucial role as they have rapid physiological action, allow the administration of drugs for patients who cannot take oral medication, and provide a feasible alternative for active pharmaceutical ingredients that are broken down by the digestive system. These products are extremely sensitive, and need to be formulated in a manner that the products are chemically and physically stable, water soluble, compatible with the container closure system, and without any contamination.

In this session, expert speaker Lori Herz will focus on the requirements and challenges of formulating small molecule injectable products. She will provide an overview of different types of injectables and terminology that is commonly used in the industry and health agencies currently. In this hour-long session, Lori will delve into the ingredients used to formulate products, including both aqueous and non-aqueous vehicles, as well as added substances. She will discuss in detail about the function and mechanism of excipients for both liquid and lyophilized (freeze-dried) products. Because drug solubility is often an issue during formulation development, she will address strategies for improving solubility. Sometimes, it can be advantageous to have products that are released over a long period of time, rather than immediately. To achieve this, there are numerous sustained release techniques that have been developed, such as the use of microspheres and liposomes, which are also covered in the discussion.

The next major topic in the audio conference will be containers and closures, also known as packaging components. These items play a critical role in patient safety, as well as the protection and performance of the product, and she will cover the FDA’s specific requirements for container closure systems. Plus, our expert will also discuss different types of packaging components, including traditional items, such as glass vials and rubber stoppers, as well as newer systems, such as pre-filled and dual chamber syringes. This section of the talk will also include extractables and leachables testing for closures and for other single-use technologies used in pharmaceutical manufacture.

In the end, she will conclude with a discussion on the ICH Quality Guidance and Pharmaceutical Development (Q8) — since the formulation design plays a key role in product development and has a significant impact on a product throughout its entire lifecycle.

Topics covered in the session:

  • Introductory concepts
    • Types of injectables, routes of administration
  • Ingredients
    • Vehicles and added substances
    • Excipients used in liquid and lyophilized (freeze-dried) products
    • Formulation strategies to improve solubility
  • Sustained release techniques
  • Containers & closures
    • Traditional types and characteristics
    • New packaging systems
    • Extractables and leachables
  • ICH Q8 Pharmaceutical Development
    • Role of development in the product lifecycle

Plus, she will also cover:

  • Challenges frequently faced
    • Formulation - handling difficult to solubilize actives
    • Packaging - glass delamination
  • Examples of new technologies
    • Sustained release
    • Novel packaging systems
    • References for additional information on topics presented

Who should attend

  • Junior level formulation scientists and industrial pharmacists
  • Process development scientists and engineers
  • Manufacturing engineers and managers
  • Quality assurance and quality control personnel

Ask a question at the Q&A session following the live event and get advice about the conference from our expert speaker.

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About Our Speaker

Lori Herz - Pharma Training Expert

Lori Herz, Ph.D. is currently a Professor of Practice of Chemical Engineering at Lehigh University. She is the Associate Director of the Bioengineering Program at Lehigh, where she teaches the Metabolic Engineering and Biotechnology Laboratory courses. Additionally, she is affiliated with the Integrated Product Development program, for which she advises student teams working on their capstone design projects.

Prior to joining Lehigh, Dr. Herz worked at Bristol-Myers Squibb...   More Info
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