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Technology name
Last update: Aug 2024Thin Film Polycaprolactone Device Implant
Developer(s)
Sponsor(s)
Not specified
Type of technology
Polymer-based particles
Administration route
Subcutaneous, Intra-vitreal
Development state and regulatory approval
Rilpivirine (RPV)
Pre-clinical
Not provided
Description
Thin Film Polycaprolactone Devices (TFPDs) are novel, biodegradable platforms designed for subcutaneous or ocular administration, capable of sustained release of both small and large molecules. By manipulating the polycaprolactone (PCL) polymer's degradation profile, fabrication parameters, and characterization. TFPDs can be tailored to achieve desired pharmacokinetic profiles for a wide range of APIs. This technology has the potential to deliver a linear release rate for up to three months.
Developer(s)
University of California
The University of California (UC) was founded in 1868 with the establishment of its first campus, UC Berkeley. Over the years, it has grown into a leading public university system with a strong emphasis on research and innovation. UC has been at the forefront of numerous scientific and pharmaceutical technological advancements in alliance with external collaborators.
Technology highlight
• Biodegradable material • Suitable for subcutaneous and ocular administration • Customizable release rate, duration, and storage stability • Minimal invasive application (no sutures or anesthesia required)
Illustration(s)
Technology main components
1) Multilayer of different variations of Polycaprolactone (PCL) membranes 2) Polymers: Polyethylene glycols, cyclodextrins, polysorbates, and co-polymers such as poloxamers 3) Stabilizers 4) Preservatives including Antioxidants 5) Release Modifiers 6) PDMS (Polydimethylsiloxane) annulus 7) Dyes 8) Emulsifiers 9) Other additives are added based on API's physicochemical properties such as inert fillers, anti-irritants, gelling agents, surfactants, emollients, coloring agents, buffering agent 10) Pore-forming agent (eg: Gelatin)
Not provided
Safety, Efficacy and Evidence Summary
Safety studies in humans are yet to be conducted.
Not provided
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APIs compatibility profile
The target compounds encompass a broad spectrum of therapeutic classes, including immunosuppressants such as methotrexate, antiglaucoma, anti-inflammatory, immunosuppressant, vitamin, micronutrient, antioxidant, antibacterial (e.g., vancomycin, cephazolin), antiviral (e.g., ganciclovir, acyclovir, foscarnet), antifungals (e.g., amphotericin B, fluconazole, voriconazole), anticancer agents (e.g., cyclophosphamide, melphalan), vitamins, zinc, copper and zeaxanthin.
TFPD system is developed for a range of therapeutic proteins, including: VEGF inhibitors, hematopoietic factors such as erythropoietin, thrombolytic agents like tissue plasminogen activator, collagenolytic enzymes like hyaluronidase and microplasmin, immunomodulatory agents such as etanercept, infliximab, and daclizumab, neuromuscular agents like botulinum toxin A, complement inhibitors targeting the C3 component, antibody therapeutics including ranibizumab, bevacizumab, trastuzumab and other molecules such as insulin, interferon alpha-2b.
Not provided
The stability of the API within the TFPD device reservoir was assessed, devices containing residual API were opened, and the contents were dissolved in a release buffer. The API purity was then quantified using reverse-phase high-performance liquid chromatography (RP-HPLC). This analytical method effectively separates the API from process impurities and degradation products generated during the manufacturing process. The results demonstrated that the API purity remained consistent within the device reservoir for up to 49 days of storage. However, a significant decrease of 19% in API purity.
75-90 wt%
1 single API : i
Not provided
Scale-up and manufacturing prospects
Not provided
The fabrication of the TFPD system utilized two primary pieces of equipment: a circular mold and a laser beam. Other equipments were not disclosed.
Fabrication of the TFPD involves a few steps that include 1)Spin casting PCL +Gelatin onto a flat circular mold 2)A mixture of polycaprolactone (PCL) and gelatin is spin-cast onto the mold to form a uniform polymer layer. 3)A drug pellet or solution is applied to the bioagent layer positioned between two PCL layers. 4)The assembled layers are dried using either an evaporation or lyophilization technique. 5)A heated PDMS annulus is applied to seal the polymer layers at 80°C. 6)The sealed device is subjected to lyophilization to remove moisture. 7) At last Zinc oxide nanowire rod is integrated.
1) Scanning Electron Microscope 2) XP - 2 Stylus Profiler 3) SpectraMax 190 microplate reader
Excipients & delivery device(s)
No proprietary excipient used
No novel excipient or existing excipient used
No residual solvent used
Thin Layer Polycaprolactone Device
Additional features
- Biodegradable
- Drug-eluting
- Monolithic
- Room temperature storage
The release rate (constant) of the API is tunable based on the characteristics of the targeted API. In TFPD, the dissolved drug is driven by a concentration gradient between the drug-laden reservoir and the external environment and partitions into the polymeric membrane. Subsequently, the drug diffuses through the membrane and into the surrounding bulk fluid. Preclinical studies of tenofovir show that the API undergoes a linear release rate ranging from 0.5 to 4.4 mg/day for 60-90 days.
TFPD administration involves a minor surgical procedure and non injectable. The device is inserted into the subcutaneous tissue via a small incision made in the skin.
Stability studies conducted on TFPD devices loaded with API demonstrated that the purity of the API remained unchanged within the device reservoir for a storage period of up to 49 days.
TFPD is customizable to an acceptable storage condition depending on the indication and target patient population.
Therapeutic area(s)
- HIV
- Pre-Exposure Prophylaxis (PrEP)
Potential associated API(s)
- Elvitegravir (EVG)
- Rilpivirine (RPV)
- Tenofovir alafenamide (TAF)
Use of technology
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
Weekly, Monthly
Targeted user groups
- Adults
- Older Adults
- All
Unspecified
Unspecified
Unspecified
Not provided
Elvitegravir (EVG)
Antiretroviral agent
Pre-clinical
Not provided
HIV
Not provided
Not provided
Not provided
Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
Pre-clinical
Not provided
HIV
Not provided
Not provided
Not provided
Nucleoside reverse transcriptase inhibitors (NRTIs)
Pre-clinical
Not provided
Not provided
Not provided
Not provided
Not provided
Multilayer Thin Film drug delivery Device and Methods of making and using the same
Multilayer thin film devices that include a bioactive agent for elution to the surrounding tissue upon administration to a subject are provided. The multilayer thin film devices are useful as medical devices, such as ocular devices. Also provided are methods and kits for localized delivery of a bioactive agent to a tissue of a subject, and methods of preparing the subject devices. The multilayer thin film medical device includes a first layer, a bioactive agent, and a second layer. The first and the second layers may be porous or non-porous. The devices have a furled structure, suitable for administration to a subject.
US11185499B2
Device
The Regents of the University of California
Not provided
April 12, 2032
Not provided
All sponsors
No sponsor indicated