FDA Latest Industry Guidance for Liposome Drug Products

Liposome Drug Products
Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation
It provides specific labeling requirements for liposome versus pegylated liposome.
The nonproprietary name of a drug product approved under the Federal Food, Drug, and Cosmetic Act is its established name, which , in most instances , will be the United States
Pharmacopeia (USP) drug product monograph title for that product. If there is no USP monograph for the liposome drug product, you should refer to 21 CFR 299.4, USP General
Chapter <1121> Nomenclature, and the USP Nomenclature Guidelines. The liposome drug product nonproprietary name should include terminology to express that the product is a liposome or a pegylated liposome. Examples:
[DRUG] Liposome Type X [DOSAGE FORM]
[DRUG] Pegylated Liposome Type X [DOSAGE FORM]
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Nektar – PEGylated opioid analgesic Reported positive Phase 3 clinical trial results

A short polyethylene glycol (PEG) and its pegylation to small molecules could make a huge difference. Nektar announced positive topline results from an oral Human Abuse Potential (HAP) study of NKTR-181, which is a first-in-class opioid analgesic.  NKTR-181 is a pegylated small molecule drug: a short PEG with six repeating ethylene glycol units conjugated to a compound which shares the same core structure with Oxycodone, a semisynthetic opioid. Based on Nektar website, the U.S. Food and Drug Administration (FDA) has granted the investigational medicine NKTR-181 Fast Track designation for the treatment of moderate to severe chronic pain.

“The NKTR-181 HAP study was designed to confirm and assess the relative oral abuse potential of NKTR-181 at its maximum analgesic or therapeutic dose (400 mg) and at a supratherapeutic dose (3 times to 12 times greater than its analgesic dose range of 100 mg to 400 mg) compared to common therapeutic doses of a Schedule II opioid, oxycodone. Its study’s primary efficacy endpoint demonstrated significantly improved chronic back pain relief with NKTR-181 compared to placebo (p=0.0019). Key secondary endpoints of the study also achieved high statistical significance. The study demonstrated that NKTR-181 had a favorable safety profile and was well tolerated.”

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Marketed PEGylated Drugs Approved by FDA and in Europe

An excellent review article is published by scientists from Nektar Therapeutics, Bayer, Jansen, and Baxalta Innovations GmbH in the journal of Journal of Pharmaceutical Sciences.

Journal of Pharmaceutical Sciences 105 (2016) 460-475
Since 1990, 12 PEGylated biopharmaceuticals have been introduced into the market place as drugs for human use (Table 1).Eleven are PEGylated protein biopharmaceuticals and one is aPEGylated aptamer (Macugen) administered intravitreally. Adagen®, Krystexxa®,
Neulasta®, Oncaspar®, PEG-Intron®, Somavert®, and Plegridy® are PEGylated with PEG molecules having molecular weight of 5-20kDa. Cimzia®, Macugen®, Mircera®, Omontys®, and Pegasys®are PEGylated with PEG molecules of 30 or 40 kDa.
Marketed PEGylated Drugs
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Custom Synthesis Options at Creative PEGWorks

green liquid in beaker being added to test tube

Do you need a special PEG reagent synthesized? You’re in luck! At Creative PEGWorks, we handle custom synthesis service for polyethylene glycol (PEG) and other polymers.

Working with a wide variety of functional groups and broad range of molecular weights, we frequently provide custom synthesis of:

  • Functional polymers: Design and synthesis of functional polymer derivatives like polyamino acid, PEG (polyethylene glycol), polyester, and glycosylated and PEGylated biodegradable polymers
  • Small molecules: Design and synthesis of novel organic molecules, API intermediates, stereoisomers, specialty amino acid derivatives, and oligomers
  • Monodispersed PEG: Design and synthesis of monodispersed PEG derivatives with functional groups used in PEGylation chemistry.

When you’re ready to get started with your custom synthesis, contact Creative PEGWorks for a quote.

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Benefits of PEGylation in the Pharmaceutical Industry

covalent bond for polyethylene glycol

Wondering if you should use PEGylation for your products? There are a number of reasons to start using the PEG polymer, including the following benefits:

  • It’s a low-cost additive.
  • It reduces immunogenicity.
  • It provides prolonged residence time.
  • It has improved formulation properties.
  • It can improve product yields.

If you’re looking for a company to handle your PEGylation needs, contact Creative PEG Works, a biotechnology company located in North Carolina. We specialize in PEGylation as well as polymer modification, particle surface functionalization, and custom synthesis of reactive oligomers and polymers of many different molecular weights.

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Novel PEG hydrogel as 3D synthetic extracellular matrix (ECM) for organoid culture

A recent article published in the leading scientific journal of Nature (Designer matrices for intestinal stem cell and organoid culture, Matthias P. Lutolf et al from the Ecole Polytechnique Fédéra…

Source: Novel PEG hydrogel as 3D synthetic extracellular matrix (ECM) for organoid culture

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Novel PEG hydrogel as 3D synthetic extracellular matrix (ECM) for organoid culture

A recent article published in the leading scientific journal of Nature (Designer matrices for intestinal stem cell and organoid culture, Matthias P. Lutolf et al from the Ecole Polytechnique Fédérale de Lausanne (EPFL) in Switzerland, Nature, Published online 16 November 2016,  doi:10.1038/nature20168) reported the first intestinal and colorectal cancer organoid culture in fully defined extracellular matrix (ECM). Enzymatically crosslinked PEG hydrogel was used to modulate the 3D synthetic networks to support organoid formation. Organoids formed by self-organizing stem cells resemble their native counterparts in cellular content, multicellular architecture and functional features. This novel approach overcomes multiple limitations of current organoid cultures and greatly expands their applicability in basic and clinical research. The principles presented in this publication may be extended to identify designer matrices that are optimal for long-term culture of other types of stem cells and organoids. The authors stated that one of the aims is to mimic the basic physical properties of Matrigel without contributing any biochemical signals.

Creative PEGWorks congratulates this significant advancement in PEG hydrogel and their use in regenerative medicine. We are proud that our multi-arm PEG reagents (e.g. 8-Arm PEG-Acrylate) are used in this great work.

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