BOC Sciences is committed to providing customers with pre-prescription research, formulation process development, analytical method development and verification, clinical sample production, registration declaration and One-stop formulation development services for commercial production. No matter what stage the project is in, we will tailor an exclusive project strategy for the client, in order to push the drug preparation to the clinical trial and market as soon as possible.
We use professional solid dispersion technology, clathrate technology, microencapsulation, liposome preparation technology, in vitro dissolution/in vivo PK comprehensive evaluation, etc., to provide a full range of services related to pharmaceutical preparation research.
Relying on years of experience in formulation development, we have equipment commonly used for formulation research in various dosage forms such as tablets, capsules, granules, injections, oral solutions, eye drops, nasal sprays, creams, ointments, and gels. In addition, we also have the ability to develop high-end preparation technologies such as inhalation drug delivery, transdermal drug delivery, and sustained and controlled release drug delivery.
Service Content
BOC Sciences is committed to providing customers with systematic one-stop drug preparation research services, the main services are as follows:
- Pre-formulation Studies
By using very small amounts of active pharmaceutical ingredients (APIs) or druggable candidate compounds, the specialized pre-formulation studies provided by BOC Sciences can provide valuable information to inform the next steps in research.- The solubility, water content, particle size, crystal characteristics, biological activity and osmotic pressure of the raw material drug, etc.
- The effect of excipients on drugs, such as anti-oxidation, enhanced penetration, and controlled release.
- Raw material compatibility test.
- Formulation Technology Research
According to the characteristics of the dosage form, combined with the physical and chemical properties and stability of the drug, considering the production conditions and equipment, conduct preparation technology research, preliminarily determine the preparation technology and process of laboratory samples, and establish corresponding process control indicators.
- Preparation Quality Research
BOC Sciences has an experienced team of CMC experts to provide customers with stable and high-quality preparation quality research services.
- Laboratory-scale Preparation Testing
Laboratory-scale preparation testing is mainly engaged in exploratory, developmental work, method development and optimization. The preparation laboratory of BOC Sciences is equipped with small-scale equipment corresponding to various dosage forms such as oral, injection, and external use, including hot melt extruder, wet mixing granulator, dry granulator, high-efficiency coating machine, tablet press, freeze dryer, spray dryer, etc.
- GMP-based Clinical Sample Production & Packaging
BOC Sciences has established a GMP-compliant preparation workshop with advanced equipment and complete functions to provide corresponding drug production and packaging services for clinical trial research.
- Formulation Stability Study
BOC Sciences designs protocols for stability studies based on products in different dosage forms to ensure compliance.
- Consistency Evaluation
BOC Sciences has accumulated rich experience in the development of generic drugs, and can currently provide all services in the pharmaceutical part of consistency evaluation, including drug formulation and process optimization, pilot scale-up, dissolution curve fitting of generic and reference preparations, methodological research, in-depth comparison of impurity profiles, stability research, and formulation of quality standards, and assist in the formulation of scientifically reasonable bioequivalence test protocols.