Liposome Drug Products
Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation
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]
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.”
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.
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.
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