PCL Formulation Development

PCL Formulation Development

BOC Sciences has established an interdisciplinary and multifunctional R&D platform to provide end-to-end solutions for polycaprolactone (PCL) and its microspheres, ranging from material design to injectable formulation development, from process development to quality control. Whether for drug sustained release, cosmetic nutrient release, or dermal filling in the aesthetic field, BOC Sciences offers comprehensive technical support and customized solutions. With our efficient R&D capabilities, stringent quality management system, and leading manufacturing technologies, we help clients gain a competitive edge in their respective fields.

Core Competencies of BOC Sciences in PCL Formulation Development

Custom Synthesis and Modification of PCL

We can synthesize PCL and its copolymers with different molecular weights, end-group structures, and block configurations according to customer requirements, laying a solid foundation for the controllability of subsequent microsphere performance and drug release profiles.

Precision Control of Microsphere Particle Size

With advanced emulsification systems and particle size grading equipment, we achieve tunable particle sizes in the range of 10–100 microns and precise D90 control, ensuring good injectability and uniform tissue distribution of microspheres to meet clinical standards.

Multiple Emulsification and Drying Techniques

We master various microsphere preparation technologies and can select optimal methods based on the physicochemical properties (hydrophilic or hydrophobic) of active ingredients and target product forms (solid powder, liquid suspension), improving drug loading efficiency and final product stability.

Design of Microsphere Products

We design microsphere structures and encapsulation strategies tailored to different cosmetic or therapeutic purposes, enabling mechanisms such as tissue stimulation, volume support, or sustained release of active components to meet diversified market demands and product positioning strategies.

Pilot Scale-Up and GMP-Standard Production

We provide process optimization services to transition from laboratory preparation to pilot scale, support technical transfer and equipment matching for client production lines, and assist in the preparation of cGMP-compliant batch samples and registration documentation.

Quality Control Systems

We have established a complete quality testing platform covering key parameters such as particle size, drug release, residual solvents, endotoxins, and biocompatibility, ensuring that PCL microsphere products meet international and regional regulatory standards for global registration and submission.

PCL Formulation Services Offered by BOC Sciences

With advanced R&D equipment, excellent formulation design capabilities, and a rigorous quality management system, BOC Sciences provides customized PCL and microsphere formulation solutions for industries such as medical aesthetics, cosmetics, and biomedicine. Whether as sustained-release carriers for active ingredients, sensory-modulating components, or dermal fillers in medical aesthetics, BOC Sciences delivers scientifically sound and efficient formulation designs. Our PCL microspheres offer excellent biocompatibility and controlled degradability, ensuring the stable release of active ingredients and enhancing both therapeutic efficacy and user experience.

High Molecular Weight HA

Sustained-Release Carrier Formulations for Active Ingredients

We design specialized PCL microsphere sustained-release carrier formulations for various skincare products such as creams, serums, and facial masks. These formulations can encapsulate highly active ingredients such as vitamins, peptides, coenzyme Q10, dexamethasone, and hyaluronidase regulators for long-term release.

Medium Molecular Weight HA

Formulations for Sensory-Modulating Components

BOC Sciences also provides PCL microsphere formulations aimed at enhancing sensory experiences, especially for foundations, lotions, and exfoliating products. These microsphere formulations ensure stable release of sensory ingredients while improving application comfort, durability, and breathability to provide consumers with a better usage experience.

Low Molecular Weight HA

Dermal Filler Formulations

In the medical aesthetics field, we optimize PCL particle molecular weight, crosslinking degree, and solvent systems based on client needs to ensure PCL dermal fillers possess excellent stability, biocompatibility, and long-lasting effects. Our team can also incorporate bioactive molecules tailored to specific applications to enhance skin repair and regeneration capabilities.

Oligomeric HA

Sustained-Release Drug Carrier Formulations

In the biomedical field, BOC Sciences develops PCL microsphere formulations for drug carriers such as vaccine adjuvants and tissue engineering scaffolds. These microspheres can effectively encapsulate vaccine components or growth factors, ensuring their stability and sustained release in the body, thereby improving vaccine immunogenicity or promoting tissue repair.

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PCL Formulation Development Technology at BOC Sciences

BOC Sciences possesses advanced technical capabilities in the field of PCL microsphere formulation development. Through precise design and innovative processes, we ensure optimal functionality, stability, and performance for each formulation. Using modern molecular design techniques and leading microsphere preparation technologies, we custom-optimize the structure of PCL and the release characteristics of microspheres based on specific application requirements. From microsphere design and fabrication to injectable formulation development, we provide full technical support throughout all stages, ensuring excellent biocompatibility, drug-loading capacity, and sustained-release performance.

Material Selection and
Structural Design

In the early stage of PCL microsphere formulation development, BOC Sciences systematically screens PCL materials for molecular weight, crystallinity, end-group functionality, and copolymerization compatibility with other polymers (such as PLA, PEG, and PLGA) to determine a suitable structural backbone. We can also introduce degradable regulatory monomers or bio-recognition groups to achieve controlled degradation and targeting properties in vivo.

Optimization of Microsphere Forming Process

BOC Sciences employs various processes such as solvent evaporation, double emulsion, spray drying, and membrane emulsification. Depending on the target product's particle size distribution, drug loading, and release kinetics, we flexibly select the optimal preparation route. Through parameter control (e.g., stirring speed, emulsifier type, oil-water ratio), we achieve high uniformity and precise particle size control of microspheres.

Drug-Loading Strategies and Controlled-Release Mechanism Design

BOC Sciences supports encapsulation of various active ingredients, including small-molecule whitening agents, antioxidants, peptides, vitamins, and growth factors. We apply diverse drug-loading strategies such as physical embedding, co-dissolution, interfacial adsorption, or layered structures. By leveraging polymer hydrophilic-hydrophobic interactions, we realize controlled-release effects for different drugs.

Stability and System Compatibility Evaluation

We focus on evaluating formulation system stability, including microsphere suspension stability, drug retention, particle uniformity, and compatibility with external systems (such as hyaluronic acid matrices, phosphate buffer, and liposome systems). Using thermal cycling, pH stability testing, and mechanical shear simulations, we ensure the physicochemical stability of microspheres during storage, transportation, and clinical application.

GMP Manufacturing Capabilities for PCL Formulations

BOC Sciences operates a complete GMP-certified production system, providing full-service support from laboratory R&D and pilot-scale development to large-scale GMP production. Our R&D team is dedicated to exploring and developing new formulations and processes to maintain optimal product quality during production. In the pilot development phase, we simulate large-scale production processes through small-batch manufacturing to ensure a seamless transition to GMP production. Additionally, we have a professional quality control team that performs comprehensive testing on each batch of PCL microspheres, including particle size distribution, drug release characteristics, and residual solvents, to guarantee product stability and safety. For technical support, we offer complete production records and reports to assist clients in regulatory registration and help them successfully pass market approvals.

Quality Testing Services for PCL Formulations

BOC Sciences offers comprehensive quality testing services for PCL microsphere formulations to ensure that each batch meets rigorous performance and quality standards. Our quality assessment system covers both in vitro and in vivo testing, enabling a thorough evaluation of key indicators such as drug release characteristics, biocompatibility, and stability of the microspheres. Through advanced analytical technologies, we provide precise performance characterization and quality evaluation to ensure the product performs efficiently across various applications. From in vitro release tests to in vivo efficacy evaluations, our testing services demonstrate strong advantages in multiple fields. With state-of-the-art instrumentation and scientific workflows, BOC Sciences delivers reliable data support to guarantee the superior performance and long-term stability of PCL microspheres.

Analytical Items

Particle size distribution Drug loading rate Drug release rate In vitro release testing Thermal analysis (DSC) Solubility testing Biocompatibility evaluation In vivo efficacy assessment Microsphere stability testing Endotoxin detection

Analytical Instruments

Dynamic light scattering (DLS) High-performance liquid chromatography (HPLC) Differential scanning calorimeter (DSC) Gas chromatograph (GC) UV-Visible spectrophotometer (UV-Vis) Inductively coupled plasma mass spectrometer (ICP-MS) Biocompatibility testing platform In vitro cell model testing platform Small animal imaging system Endotoxin detection instrument (LAL test)

Applications Supported by Our PCL Formulations

Due to their excellent biocompatibility, biodegradability, and controlled drug release properties, PCL and its microspheres are widely applied across various fields. Especially in medical aesthetics, functional cosmetics, biomedicine, and medical devices, PCL microspheres not only serve as effective drug carriers but also provide long-term release of active ingredients, enhancing product efficacy and user experience. Leveraging advanced formulation development technologies, BOC Sciences offers customized PCL microsphere formulation services to meet the strict demands for performance, stability, and biocompatibility across different industries.

Facial Filler Materials

PCL microspheres, with their favorable biocompatibility and durable support, are widely used in facial fillers for medical aesthetics. Their slow degradation allows effects lasting over a year, helping enhance facial contours, fill wrinkles, and stimulate collagen production for natural and long-lasting shaping and rejuvenation.

Sustained Release Drug Delivery

PCL microspheres enable slow drug release, reducing dosing frequency and improving treatment adherence. With adjustable degradation rates, they are suitable for encapsulating and delivering both small and large molecule drugs, widely used in cancer therapy, chronic disease management, and localized treatments.

Functional Cosmetic Encapsulation

PCL microspheres can encapsulate active ingredients such as vitamins, peptides, and antioxidants to achieve stable embedding and sustained release. By controlling the release rate, they improve the long-term efficacy and permeability of skincare products, enhance skin feel, and boost product performance, making them popular in high-end cosmetics.

Vaccine Adjuvant Carriers

PCL microspheres can serve as carriers or adjuvants for vaccines, continuously releasing antigens or immune modulators to enhance immune response. Their biodegradability and safety make them ideal delivery platforms for novel vaccine systems, including subunit and mRNA vaccines.

Wound Dressings

Wound dressings containing PCL microspheres can sustainably release antimicrobial agents or healing factors, providing a moist environment for wounds, suppressing infections, and promoting tissue regeneration. Their softness and biocompatibility suit them for chronic wounds, post-operative dressings, and burn care.

Orthopedic Scaffold Materials

Thanks to their mechanical strength and controllable degradability, PCL is used in orthopedic scaffolds. When combined with microsphere-based drug delivery, they offer both mechanical support and bone regeneration stimulation, suitable for fracture repair, bone regeneration, and artificial bone development.

Ophthalmic Implants

PCL microspheres can be used for posterior segment ocular drug delivery, such as in treatments for macular degeneration or glaucoma. They offer good transparency, biocompatibility, and tunable release capacity. Their sustained-release properties help reduce injection frequency, improving patient comfort and compliance.

Tissue Engineering Scaffolds

As a common material in tissue engineering, PCL is suitable for constructing scaffolds for soft tissue, nerve, cardiovascular, and other tissues. Microsphere systems can be loaded with growth factors to induce cell adhesion and proliferation, promoting tissue regeneration and serving as vital carrier materials in regenerative medicine.

FAQ

FAQs

What is the PCL made of?

Polycaprolactone (PCL) is a synthetic polymer material made from the polymerization of ε-caprolactone monomers and belongs to the aliphatic polyester family. It features excellent biocompatibility and biodegradability and is widely used in medicine, aesthetics, drug delivery, and tissue engineering, making it an environmentally friendly and versatile polymer.

Polycaprolactone is primarily synthesized via ring-opening polymerization of ε-caprolactone, usually in the presence of catalysts such as stannous octoate. This reaction can be conducted under mild conditions, allowing control over the molecular weight, yielding PCL with diverse physical properties for applications in medical devices, controlled-release systems, and more.

Polycaprolactone consists of repeating ε-caprolactone units with the structural formula [–(CH₂)₅COO–]ₙ. It is a linear aliphatic polyester containing ester bonds and long methylene chains in its molecular structure, which grants it excellent flexibility, processability, and controllable degradability—making it suitable for a wide range of biomaterial applications.