Next Generation Drug Delivery Systems
Next Generation Drug Delivery Systems
Selected FDA-Approved PLGA-Based Long-Acting Drug Products
PLGA and closely related PLG polymers have been used in several FDA-approved long-acting injectable and localized drug-delivery products. These formulations demonstrate the versatility of biodegradable polymer technology for weekly, monthly, multi-month and site-specific drug release.
The following table presents selected examples for technical and educational reference.
|
FDA-Approved Product |
Active Pharmaceutical Ingredient |
PLGA-Based Delivery Format |
Approved Application |
Labelled Administration Pattern |
|
LUPRON DEPOT – 1 Month |
Leuprolide acetate |
Lyophilized microspheres containing a biodegradable copolymer of lactic and glycolic acids |
Treatment of advanced prostate cancer |
Intramuscular administration every four weeks |
|
SANDOSTATIN LAR DEPOT |
Octreotide acetate |
Biodegradable glucose-star PLGA microspheres |
Acromegaly and symptoms associated with certain carcinoid tumours and VIPomas |
Intramuscular administration every four weeks |
|
RISPERDAL CONSTA |
Risperidone |
Risperidone encapsulated in 75:25 polylactide-co-glycolide microspheres |
Schizophrenia and maintenance treatment of Bipolar I Disorder |
Intramuscular administration every two weeks |
|
VIVITROL |
Naltrexone |
Extended-release PLG microsphere formulation |
Alcohol dependence and prevention of relapse to opioid dependence following detoxification |
Deep intramuscular administration every four weeks or once monthly |
|
TRELSTAR |
Triptorelin pamoate |
Sterile, lyophilized PLGA biodegradable microgranules |
Treatment of advanced prostate cancer |
Intramuscular administration every 4, 12 or 24 weeks, depending on strength |
|
BYDUREON BCISE |
Exenatide |
Extended-release microspheres containing 50:50 poly(D,L-lactide-co-glycolide) |
Improvement of glycaemic control in patients with Type 2 diabetes mellitus, as specified in the approved label |
Subcutaneous administration once every seven days |
|
ZILRETTA |
Triamcinolone acetonide |
75:25 PLGA microspheres for localized extended release |
Management of osteoarthritis pain of the knee |
Single intra-articular injection according to the approved label |
|
SIGNIFOR LAR |
Pasireotide pamoate |
Active ingredient distributed within biodegradable PLGA microspheres |
Treatment of acromegaly and Cushing’s disease in specified patient groups |
Intramuscular administration once every four weeks |
What These Products Demonstrate
These FDA-approved products illustrate that there is no universal PLGA grade for every sustained-release formulation. The appropriate polymer must be selected according to the active ingredient, intended route of administration, desired release period and manufacturing process.
Critical polymer attributes may include:
· Lactide-to-glycolide ratio
· Molecular weight and molecular-weight distribution
· Inherent viscosity
· Acid or ester end group
· Linear, branched or glucose-initiated architecture
· Polymer degradation behaviour
· API–polymer interaction
· Microsphere particle size and morphology
· Residual monomer and residual solvent levels
FDA product-specific guidance for complex PLGA formulations may require comparative evaluation of polymer composition, molecular weight, molecular-weight distribution, architecture and other physicochemical characteristics during generic-product development.
PLGA Polymer Selection Support from Nomisma Healthcare
Nomisma Healthcare supports pharmaceutical formulators with high-purity PLGA polymers for microspheres, long-acting injectables and controlled-release drug-delivery systems.
Our portfolio includes multiple lactide-to-glycolide ratios, molecular-weight ranges, inherent viscosities and end-group options. Customized PLGA polymers can also be developed according to the required formulation process and target drug-release profile.
Our technical and analytical capabilities support:
· Selection of suitable PLGA grades
· Customized molecular-weight development
· Acid-, ester- and glucose-initiated polymers
· Polymer composition and end-group analysis
· Molecular-weight distribution testing
· Reference-product polymer characterization
· Microsphere morphology and particle-size evaluation
· Residual monomer, solvent and moisture testing
Discuss your PLGA microsphere project with the Nomisma Healthcare technical team to identify a suitable polymer for your formulation-development requirements.
Regulatory and Accuracy Notice
The products listed above are included only as publicly available examples of FDA-approved finished drug products that use PLGA, PLG or related biodegradable polymer-delivery technology.
The information does not constitute medical or prescribing advice and should not replace the current FDA-approved prescribing information.
The listing does not imply that Nomisma Healthcare manufactures or supplies the polymer used in these branded products. FDA approval of a finished drug product does not represent FDA approval, certification or endorsement of Nomisma Healthcare or any specific excipient supplier.
All trademarks and brand names belong to their respective owners.