Lipid-Based Drug Delivery Systems Community

Dear Dimple,

I have developed formulations for pharmaceuticals and nutraceuticals to support pre-clinical through Phase III studies.  My strategy, from an excipient acceptability for use has been to stay within the Inactive Ingredient Database limits. The excipients used in lipid-based formulations are safe, and often derived from natural products.  I have been careful to use quality by design approach for formulation development and developed QTTP and identified critical material attributes and critical processing parameters for the formulations I have developed.  This approach is standard for all formulation types.  Some nuances for LBDDS are characterization of formulation performance through both dispersion and lipolysis testing.  Given that the excipients are often complex mixtures of triglycerides, monoglycerides, fatty acids, etc, I have been sure to screen multiple lots of excipients, including where possible, including lots with broad ranges in a given critical material attribute.  

Dear Dimple,

I have developed formulations for pharmaceuticals and nutraceuticals to support pre-clinical through Phase III studies.  My strategy, from an excipient acceptability for use has been to stay within the Inactive Ingredient Database limits. The excipients used in lipid-based formulations are safe, and often derived from natural products.  I have been careful to use quality by design approach for formulation development and developed QTTP and identified critical material attributes and critical processing parameters for the formulations I have developed.  This approach is standard for all formulation types.  Some nuances for LBDDS are characterization of formulation performance through both dispersion and lipolysis testing.  Given that the excipients are often complex mixtures of triglycerides, monoglycerides, fatty acids, etc, I have been sure to screen multiple lots of excipients, including where possible, including lots with broad ranges in a given critical material attribute.  

Hello Dimple, I have developed topical and ophthalmic formulations that were subjected to various physicochemical and stability tests and followed through clinical batches. The lipid excipient purity was found to be a big factor, as the lipids are responsible for the physical stability of the formulation. The breakdown of glycerides is dependent on the purity of a given lipid. 

Dear Dimple,

I have developed formulations for pharmaceuticals and nutraceuticals to support pre-clinical through Phase III studies.  My strategy, from an excipient acceptability for use has been to stay within the Inactive Ingredient Database limits. The excipients used in lipid-based formulations are safe, and often derived from natural products.  I have been careful to use quality by design approach for formulation development and developed QTTP and identified critical material attributes and critical processing parameters for the formulations I have developed.  This approach is standard for all formulation types.  Some nuances for LBDDS are characterization of formulation performance through both dispersion and lipolysis testing.  Given that the excipients are often complex mixtures of triglycerides, monoglycerides, fatty acids, etc, I have been sure to screen multiple lots of excipients, including where possible, including lots with broad ranges in a given critical material attribute.  

Dear Dimple,

I have developed formulations for pharmaceuticals and nutraceuticals to support pre-clinical through Phase III studies.  My strategy, from an excipient acceptability for use has been to stay within the Inactive Ingredient Database limits. The excipients used in lipid-based formulations are safe, and often derived from natural products.  I have been careful to use quality by design approach for formulation development and developed QTTP and identified critical material attributes and critical processing parameters for the formulations I have developed.  This approach is standard for all formulation types.  Some nuances for LBDDS are characterization of formulation performance through both dispersion and lipolysis testing.  Given that the excipients are often complex mixtures of triglycerides, monoglycerides, fatty acids, etc, I have been sure to screen multiple lots of excipients, including where possible, including lots with broad ranges in a given critical material attribute.  

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Dimple Modi
Investigator
GlaxoSmithKline
Gilbertsville PA
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Hi

This is a very broad question and regulation may base on route of administration. Recently, FDA release guidance document for liposomal liposome drug products (Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation).

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/liposome-drug-products-chemistry-manufacturing-and-controls-human-pharmacokinetics-and

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Thilak Mudalige Ph.D.
Research Chemist
US Food and Drug Administration
Jefferson AR
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.

Original Message:
Sent: 03-11-2024 23:07
From: Dimple Modi
Subject: Regulatory consideration and challenges for LBDDS

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Dimple Modi
Investigator
GlaxoSmithKline
Gilbertsville PA
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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