Our Technology and Products > Injectable Solid Implants

Injectable Solid Implants

Brookwood Pharmaceuticals is capable of delivering both biodegradable and non biodegradable polymeric implants.

Extrusion / implant capabilities include fibers, filaments, rod-shaped devices and three-dimensional composites.

Proprietary implant technology

Advantages

• Higher drug loading
• Smaller implant
• Lower immediate release

Goals for new products

• Smaller implants for easier administration and local delivery
• Implants with higher drug content

Smaller implants and more drug means faster release, including faster immediate releases

Brookwood process technology

• Make implants at desired drug loading and size
• Solvent treat surface of the implant
• Throughly dry blend particles of drug and polymer excipient
• Add blend to melt extruder
• Extrude fiber with desired diameter and surface morphology
• Cut the fibers into desired lengths to make rod segments
• Expose each rod segment with appropriate process solvent for a very short period of time (seconds)
• Dry the rod segment to evaporate away the process solvent

Goals for next-generation products

• Smaller implants for easier administration and local delivery
• Implants with higher drug content

Results

• Achieve longer durations of release
• Useful for less potent drugs
• Ability to delivery higher doses

In House Analytical Capabilities

• HPLC - UV, refractive index, evaporative light scattering detection, fluorescence
• GPC
• Inherent viscosity
• Water determination (Karl Fischer)
• Osmolality
• Particle size determination
• Differential scanning calorimetry / thermo gravimetric analysis
• BCA protein assay
• ELISA
• Gel electrophoresis
• Raw materials analysis
• FTIR, titrations, potentiometric titrations, pH determination, SDS-page

Injectable solid implants are rod-shaped devices with drug dispersed throughout a polymer matrix. They are designed to release the drug at a programmed rate for days, weeks, or months. This type of drug delivery dosage form is especially suitable when efficacy is dependent on delivering a relatively large dose of a drug over a long duration. Most classes of drugs can be formulated into these implants, particularly small molecules and peptides. The polymer matrix controls the rate of release of drug from the implant. Brookwood is developing long-acting implants with biodegradable and non-biodegradable polymers. Biodegradable implants resorb after drug release. Non-biodegradable implants can be retrieved either during or after drug release.

Brookwood has several approaches to produce injectable solid implants. One approach is to melt-extrude a blend of drug and polymer. Extrusion processes can be designed to produce matrix implants with or without an outer rate-controlling polymer shell. Implants can be used for systemic delivery (subcutaneous or intramuscular) or local delivery (ocular or CNS).

Among current development activities, Brookwood is developing an injectable implant formulation for Clinuvel which provides controlled release of CUV1647 for prevention of ultraviolet-light-related skin damage, in general, and melanoma, in particular. This product is in Phase II clinical trials.

Adding to our capabilities is the recent acquisition of Alkermes’ Medisorb® external Polymer Business. We created a Brookwood wholly owned subsidiary, Lakeshore Biomaterials, to focus on the manufacture and sale of biomaterials such as lactide/glycolide polymers. This relationship allows Brookwood to control one of the critical raw material components of injectable solid implants and drug delivery devices. In addition to ensuring Brookwood control of its partnered products from the raw material stage through final dosage form, this acquisition also allows for access to custom-prepared polymers.

Injectable solid implants are rod-shaped devices with drug dispersed throughout a polymer matrix.