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Camurus. (n.d.). Technology. Retrieved June 20, 2024, from https://www.camurus.com/science/technology/.
Based on public information

Technology name

Last update: Jul 2026

FluidCrystal®

Developer(s)

Sponsor(s)

Not specified

export_notes
Based on public information

Type of technology

Based on other organic particles, Amphiphile-based

Administration route

Subcutaneous, Intravenous, Optical

Development state and regulatory approval

Active Pharmaceutical Ingredient (API)

Buprenorphine

Development Stage

Marketed

Regulatory Approval

Buprenorphine long acting is approved under the brand name - Brixadi by US FDA and as Buvidal by EMA for Opoid Dependence.

Description

FluidCrystal Technology is an advanced injectable formulation utilizing endogenous lipids, characterized by low viscosity and long-acting properties. This technology enables the administration of active pharmaceutical ingredients (APIs) with controlled release durations ranging from days to months. The mechanism underlying this system involves reversed non-lamellar liquid crystalline phases, which facilitate the efficient encapsulation of APIs. These phases ensure a sustained and steady-state release of the API into the bloodstream, thereby enhancing therapeutic efficacy.

Developer(s)

Camurus
Originator
Sweden

Camurus

Camurus AB is a biopharmaceutical company that creates long-acting treatments for serious and chronic diseases. This company originated in 1991. Camurus, based on scientific understanding, aims to enhance patient outcomes through innovative therapies. They specialise in pharmaceutical commercialization and have a portfolio that includes clinical trial products as well as two FDA-approved drugs.

Technology highlight

• Self assembling lipids forms a nanostructure reversed-phase nonlamellar liquid crystal around the API in an aqueous environment • Easy and convenient administration • High treatment adherence • Adapted to prefilled syringes and pen injection devices • Small injection volume with a thin needle.

Illustration(s)

Technology main components

The level of each component varies based on the physiological and chemical properties of the API a) One or more neutral diacyl lipids and / or at least one tocopherol b) One or more 5–90% phospholipids c) One or more biocompatible , oxygen-containing, or low-viscosity organic solvents d) At least one bioactive agent is dissolved or dispersed in the low-viscosity mixture e) One or more oxygen-containing solvent selected from alcohols , ketones , esters , ethers , amides and sulfoxide

Information on the raw materials sourcing, availability and anticipated price

The price of Brixadi (FDA approved FluidCrystal drug) is 459.13 USD. Camurus obtains commercially available, high-quality sources of key components for FluidCrystal formulation.

Safety, Efficacy and Evidence Summary

Safety

A recent study aimed to evaluate the safety and efficacy of Buprenorphine administered via weekly or monthly subcutaneous (SC) injection using the FluidCrystal technology, compared to the traditional daily sublingual administration. Among the 215 patients assigned to receive SC Buprenorphine, 128 reported experiencing at least one adverse effect. The most frequently observed adverse events included injection-site pain, headache, constipation, nausea, as well as injection-site pruritus and erythema.

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided

APIs compatibility profile

API desired features
Water-soluble molecules

Water-insoluble molecules

Small molecules

Small molecules that are targeted for FluidCrystal Technology are Opioids, local analgesics, hormones, anti-emetics, local antibiotics, and prostacyclins

Proteins

Peptides & proteins that are targeted for FluidCrystal Technology are somatostatin & analogues, LHRH agonists, Glucagon & insulin, GLP-1 & analogues, MC4 agonists, and antibody fragments

Additional solubility data

Not provided

Additional stability data

Not provided

API loading: Maximum drug quantity to be loaded

< 10 wt%

LogP

Not provided

Scale-up and manufacturing prospects

Scale-up prospects

In 2022, 830,000 doses were manufactured

Tentative equipment list for manufacturing

Not provided

Manufacturing

Manufacturing and distribution of Camurus’ products is based on a multi-stage supply chain with several participants involved. Braeburn Pharmaceuticals overlooks the manufacturing of the FDA approved drugs of FluidCrystal in liaison with a third party manufacturer. The manufacturing process includes: - Compounding - Filtration - Filing The aim of the manufacturing process setup is to reduce product manufacturing waste by 20% and to increase the use of packaging material originating from sustainable sources to at least 50%.

Specific analytical instrument required for characterization of formulation

The listed analytical instrument used was HPLC with UV detection

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)

No delivery device

Additional features

Other features of the technology
  • Biodegradable
  • Drug-eluting
  • Monolithic
Release properties

Upon administration of the FluidCrystal SC injection, lamellar liquid crystal nanoparticles are formed by phospholipids in conjunction with the active pharmaceutical ingredient (API). This structural formation results in an initial burst release of the API into the fatty tissue environment. Subsequently, the plasma concentration of the API gradually decreases, yielding a near dose-proportional drug release over a target period of four weeks. Furthermore, repeated weekly administrations of the FluidCrystal product demonstrate smaller and less frequent fluctuations in the plasma concentration.

Injectability

Use a 23 to 25 gauge, 5/8-inch needle for the subcutaneous FluidCrystal injection. Clean the injection site and inject into the subcutaneous tissue of the abdomen, upper arm, or thigh, rotating sites each time.

Stability

Not provided

Storage conditions and cold-chain related features

FluidCrystal formulations are should be stored at room temperature, specifically between 20ºC to 25ºC . Within the range of 15°C to 30°C, fluctuations are allowed. In case of unexpected temperature variations, products should have a fall-back at refrigerated storage conditions.

Therapeutic area(s)

  • Other(s) : "Acromegaly, Polycystic liver disease, Genetic obesity disorders, Raynaud's phenomenon, Pulmonary arterial hypertension, Chemotherapy-induced nausea and vomiting, Endocrine disorders"
  • Pain management
  • Oncology
  • Substance use disorders
Use case(s)
  • Treatment

Potential associated API(s)

Use of technology

Ease of administration
  • Administered by a community health worker
  • Administered by a nurse
  • Administered by a specialty health worker
  • Self-administered
Frequency of administration

Weekly, Monthly

User acceptance
Not provided

Targeted user groups

Age Cohort
  • Adults
  • Older Adults
Genders
  • All
Pregnant individuals

Unspecified

Lactating individuals

Unspecified

Healthy individuals

Unspecified

Comment

Not provided

Class(es)

Analgesics

Development stage

Marketed

Clinical trial(s)

Foreseen/approved indication(s)

Opoid Dependence and Chronic Pain Management

Foreseen user group

All genders above the age of 18 years

Foreseen duration between application(s)

Once weekly (8mg, 16mg, 24mg and 32mg) and Once monthly injections (64mg, 96mg and 128mg)

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Buprenorphine long acting is approved under the brand name - Brixadi by US FDA and as Buvidal by EMA for Opoid Dependence.

Pituitary and hypothalamic hormones and analogues

Class(es)

Synthetic Stomatostatin

Development stage

Phase III

Clinical trial(s)

Foreseen/approved indication(s)

Acromegaly, Gastroenteropancreatic neuroendocrine tumors and Polycystic liver disease

Foreseen user group

Not provided

Foreseen duration between application(s)

Once monthly

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

holds Orphan Drug Designation in the EU for CAM2029 for the treatment of acromegaly

Description

Lipid Depot Formulations

Brief description

The invention relates to pre-formulations made from low viscosity, non-liquid crystalline mixtures of a neutral diacyl lipid, tocopherol, phospholipid, and a biocompatible organic solvent. The bioactive agent is dissolved in the mixture, and the pre-formulation forms a liquid crystalline phase structure upon contact with an aqueous fluid. These preformulations are suitable for generating depot compositions for sustained release of active agents. The invention also relates to methods of delivery, treatment, and the use of preformulations in the manufacture of a medicament.

Representative patent

WO2005117830

Category

formulation

Patent holder

Camurus AB

Exclusivity

Not provided

Expiration date

June 6, 2035

Status

Granted in : AU, BR, CA, CN, IL, JP, KR, MX, NZ, RU, ZA, UA, EP (GB, DK, FR, DE, IS, IE, IT, NL, PL, ES, SE, CH, TR,) SG, US

Description

Depot precursor formulation comprising buprenorphine for sustained delivery of and for treatment of pain or opioid dependence

Brief description

A depot precursor formulation comprising: a) a controlled-release matrix; b) at least oxygen containing organic solvent; c) at least 12% by weigh of at least one active agent selected from buprenorphine and salts thereof, calculated as buprenorphine free base. Corresponding depot compositions and methods of treatment in pain management, by opioid maintenance and related methods are provided.

Representative patent

WO2014016428

Category

formulation

Patent holder

Camurus AB

Exclusivity

Not provided

Expiration date

July 26, 2033

Status

Granted in: AU, BR, CA, CL, CN, CO, IN, ID, JP, KR, MX, NZ, PE, SG, ZA, TH, US, EA (AM, AZ ,BY, KZ, RU, TJ, TM), EP (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, NL, NO, PL, PT, RO, RS, SE, SI, SK, TR) Pending in: AR, IL, MY, HK

Description

Composition for the delayed delivery of a peptide active agent

Brief description

A composition for the delayed delivery of a peptide active agent comprising; i) a salt of said peptide active agent comprising at least one positively charged peptide ion and at least one negatively charged counter-ion ii) a sustained-release delivery vehicle. Wherein said at least one negatively charged counter-ion is a halide ion, preferably a chloride or bromide ion.

Representative patent

WO2008152401

Category

formulation

Patent holder

Camurus AB

Exclusivity

Not provided

Expiration date

June 13, 2028

Status

Not provided

All sponsors

No sponsor indicated

Additional information