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Type of technology

Polymeric implant

Administration route

Subcutaneous

Development state and regulatory approval

Active Pharmaceutical Ingredient (API)

Non-nucleoside reverse transcriptase inhibitors (NNRTI), Unspecified NNRTI

Development Stage

Pre-clinical

Regulatory Approval

Not provided

Description

Reservoir implant releasing one or more active pharmaceutical agents with constant release. Implant retrievable during drug release and biodegradable after drug depletion. The implant is 2.5mm x 40 mm. One or two implants can be used simultaneously.

Developer(s)

RTI International
Originator

RTI International

Technology highlight

Bioabsorbable subcutaneous long-acting implant platform with more than 6 month duration; compatible with several potent antiretroviral classes and hormones for HIV and/or contraception; removable for up to at least 6 months (but not required); scalable manufacturing processes.

Illustration(s)

Technology main components

The implant is extruded from a GMP grade polycaprolactone (PCL) used for medical device applications and medical-grade excipients that are generally recognized as safe (GRAS) for subcutaneous administration.

Safety, Efficacy and Evidence Summary

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided

APIs compatibility profile

API desired features

Not provided

Additional solubility data

Not provided

Additional stability data

Not provided

API loading: Maximum drug quantity to be loaded

To be provided

API co-administration

2 different APIs : Two or more active pharmaceutical ingredients can be delivered

LogP

Not provided

Scale-up and manufacturing prospects

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

Excipients & delivery device(s)

Proprietary excipients used

No proprietary excipient used

Novel excipients or existing excipients at a concentration above Inactive Ingredient Database (IID) for the specified route of administration

No novel excipient or existing excipient used

Residual solvents used

No residual solvent used

Delivery device(s)

The implant can be delivered through existing, commercially available trocars

Additional features

Other features of the technology
  • Biodegradable
  • Drug-eluting
  • Removable
  • Single-use
  • Reservoir-type
Release properties

Constant release for at least 6 months.

Injectability

Not provided

Stability

Not provided

Storage conditions and cold-chain related features

Not provided

Therapeutic area(s)

  • Contraception
  • Multipurpose technology : "HIV PrEP and contraception"
  • Other(s) : "Breast cancer (treatment and prevention)"
  • HIV
Use case(s)
  • Pre-Exposure Prophylaxis (PrEP)
  • Treatment

Potential associated API(s)

Use of technology

Ease of administration
  • Administered by a nurse
  • Administered by a specialty health worker
Frequency of administration

Every 6 months, Yearly

User acceptance
Not provided

Targeted user groups

Age Cohort
  • Adults
Genders
  • All
  • Male
  • Female
  • Cisgender female
  • Cisgender male
  • Transgender female
  • Transgender male
  • Intersex
  • Gender non-binary
Pregnant individuals

Unspecified

Lactating individuals

Unspecified

Healthy individuals

Unspecified

Comment

To be further investigated

Class(es)

NRTI ; Antiviral

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Not provided

Foreseen user group

Not provided

Foreseen duration between application(s)

Not provided

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

None

Non-nucleoside reverse transcriptase inhibitors (NNRTI) , Unspecified NNRTI

Class(es)

Antiviral

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Not provided

Foreseen user group

Not provided

Foreseen duration between application(s)

Not provided

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Not provided

Integrase inhibitors (INSTIs)

Class(es)

INSTIs, Antiretroviral

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Not provided

Foreseen user group

Not provided

Foreseen duration between application(s)

Not provided

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Not provided

Etonogestrel (ENG)

Class(es)

Hormones

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Not provided

Foreseen user group

Not provided

Foreseen duration between application(s)

1 year

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

None

Selective estrogen receptor modulators (SERMs)

Class(es)

Estrogen receptor

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Not provided

Foreseen user group

Not provided

Foreseen duration between application(s)

Not provided

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Not provided

Class(es)

NRTI; Antiviral

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Not provided

Foreseen user group

Not provided

Foreseen duration between application(s)

6 months

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

None

Levonorgestrel (LNG)

Class(es)

Hormones

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Not provided

Foreseen user group

Not provided

Foreseen duration between application(s)

Not provided

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

None

Islatravir (ISL) , Levonorgestrel (LNG)

Class(es)

antiviral (NRTI) + contraceptive hormone

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Not provided

Foreseen user group

Not provided

Foreseen duration between application(s)

6 months to 1 year

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

None