Injectable Liquid Formulations Development

As a biopharmaceutical company deeply engaged in the development of pharmaceutical formulations, BOC Sciences is committed to providing high-quality, customized injectable liquid formulation research and development services to pharmaceutical companies, biotechnology companies and research institutions around the world.

What is injectable liquid formulation?

Injectable liquid formulation refers to the sterile liquid preparation made of raw materials or appropriate excipients for injection into the body, including solution type, emulsion type and suspension type injection. It can be used for subcutaneous injection, intradermal injection, intramuscular injection, intravenous injection, intravenous injection, intrathecal injection, intraspinal injection, etc.

Types of injectable liquid formulation

Solution: A solution is the simplest form of injectable formulation in which the active pharmaceutical ingredient (API) is fully incorporated into a suitable solvent, usually water or a medium soluble with water. This uniform liquid system ensures the uniform distribution of the drug in the body, thus achieving efficient and rapid treatment results. Its clear and transparent appearance is not only an intuitive reflection of the solubility of the drug, but also a strong evidence of the stability and safety of the preparation.

Suspension: In suspension type preparations, fine drug particles are dispersed in the liquid medium to form a stable dispersion system. Unlike the dissolved state in solution, these particles remain solid, ensuring stable suspension of the drug in the body through precise control of particle size distribution and medium characteristics, effectively avoiding precipitation, and thus ensuring the continuity and effectiveness of drug delivery.

Emulsion: In the face of drugs with poor water solubility, emulsion-type preparations show their unique charm. This two-phase system is composed of oil phase and water phase, which can coexist stably through the action of emulsifier. Emulsions not only broaden the delivery route of drugs, but also provide the possibility of sustained drug release and targeted delivery, especially in improving the bioavailability of insoluble drugs, showing significant advantages.

Liposomes: Liposomes neatly encapsulate drugs in lipid bilayer structures that resemble tiny artificial cells. This vesicle system can not only protect the drug from the destruction of the internal environment, but also achieve targeted drug delivery, accurate positioning to the diseased tissue, and through the controlled release mechanism, prolong the drug action time, reduce side effects, and greatly improve the safety and accuracy of treatment.

Micellar formulations: Micellar formulations take advantage of the self-assembly properties of surfactant molecules to form a stable micellar structure, providing an innovative delivery method for drugs with poor water solubility. These micelles can not only significantly improve the solubility of drugs, but also enhance their bioavailability, promote the absorption and distribution of drugs in the body by wrapping drug molecules, and provide a more efficient and controllable means of treatment.

Advantages of injectable liquid formulation

Rapid response: Directly into the blood or target tissue, bypassing the gastrointestinal tract and first-pass effects to ensure rapid drug action.

Precise dosing: Achieving precise dosing and ensuring that patients receive the exact dose they need is especially critical for drugs with narrow treatment Windows.

Improve bioavailability: Especially for drugs with limited oral absorption, injected preparations significantly improve bioavailability to ensure effective and stable absorption of drugs to achieve therapeutic purposes.

For special groups: For patients who are unable to swallow drugs autonomously, such as coma, severe or pediatric patients, injection preparations become an important means of life extension.

Controlled release: With the help of advanced technologies such as liposomes and polymer-based systems, controlled release of drugs can be achieved, long-term therapeutic concentration can be maintained, drug administration frequency can be reduced, and patient treatment compliance can be improved.

Comprehensive formulation development services

Pre-formulation study

Solubility screening: Through detailed experimental design, the dissolution characteristics of active pharmaceutical ingredients (APIs) in various solvents are evaluated, and the most suitable injection candidates are selected to lay a solid foundation for subsequent development.

Stability testing: Stability testing under simulated real-world storage conditions to ensure that the API maintains its complete structure and activity in different environments, providing critical data support for recipe optimization.

Compatibility research: Carefully examine the interaction between API, excipients and container materials to prevent any adverse reactions that may affect the safety and effectiveness of the drug and ensure the quality of the drug.

Formulaion optimization

pH and buffer system adjustment: Through the precise adjustment of the pH value of the formula, combined with the application of highly efficient buffer system, to ensure the stable presence of the drug in the internal environment, while reducing the discomfort of injection.

Osmolality adjustment:Carefully regulating osmotic pressure so that it matches the body fluid environment to ensure patient comfort and safety during drug administration.

Innovation in dissolution technology: The use of a variety of dissolution strategies, such as pH adjustment, co-dissolution technology, the clever application of surfactants and cyclodextrins, effectively improve the solubility of insoluble drugs, breaking through traditional limitations.

Stability and sterility guarantee

Stability study: Through accelerated aging and long-term stability testing, to ensure that the formulation is stable in the shelf life and the drug activity is long-lasting.

Sterility testing: Implement high standard sterility testing procedures, thoroughly investigate the risk of microbial contamination, and ensure the safety and purity of injection preparations.

Advanced injection form technology

Liposomes and nanoparticles

Liposome encapsulation technology: The API is cleverly embedded in the lipid bilayer, which not only significantly improves bioavailability, but also achieves accurate targeted delivery and reduces systemic side effects.

Nanoparticle formulation: Using nanotechnology to improve drug solubility, stability and controlled release properties, opening up new paths for drug delivery.

Sustained release formulations

Microspheres and implants: Use biodegradable polymers to create long-lasting injectable formulations that ensure continuous drug release in the body and extend the treatment cycle.

Depot injections: carefully adjust the drug release rate, reduce the inconvenience caused by frequent medication, and improve the treatment compliance of patients.

Quality assurance of our services

Comply with good manufacturing practices (GMP)

Implementation of production standards: strictly follow the GMP guiding principles, control product quality and safety from the source, and establish industry benchmarks.

Facility certification maintenance: Production facility certification is regularly reviewed and updated to ensure that it always meets the latest regulatory requirements and demonstrates professional strength.

Analysis and characterization services

Comprehensive analytical testing: Use HPLC, GC, LC-MS and other modern analytical techniques to fully evaluate the performance of the formulation and ensure the accuracy of the data.

Characteristic research: In-depth study of the physical and chemical properties of the formula to provide scientific basis for formula optimization and quality control.

Process testing: real-time monitoring of all parameters in the production process to ensure formula consistency and process stability.

Final product testing: Complete quality testing of the finished product, including sterility, potency, pH, osmotic pressure and particulate matter checks to ensure the exceptional quality of each bottle of injection.

Why choose us?

Team of experts: The team consists of experienced scientists with deep expertise in formulation development and drug delivery systems. A multidisciplinary approach that combines chemistry, biology, pharmacology and engineering knowledge to create innovative solutions.

State-of-the-art facilities:

Customer centric: We build a close relationship with each client, ensuring smooth flow of information through regular meetings and project progress reports. We listen to your needs, understand your vision, and provide you with tailored solutions.

One-stop solution: Provide a series of end-to-end services from formulation design and optimization to scale production and regulatory filing. No matter where you are in drug development, we can support you to ensure a smooth transition to the next stage of your project.

FAQ

1. Why choose injectable liquid formulations?

Injectable formulations provide several advantages, including rapid therapeutic effect, precise dosing, improved bioavailability, and suitability for patients who cannot take oral medications. They are ideal for delivering drugs that require immediate action or those that are poorly absorbed orally.

2. What services do you offer for injectable liquid formulation development?

• Pre-formulation studies
• Formulation optimization
• Stability and sterility assurance
• Advanced formulation technologies (e.g., liposomes, nanoparticles, sustained release)
• Custom formulation development
• Analytical and characterization services
• Regulatory support
• Quality assurance and GMP compliance

3. Can you develop custom injectable formulations?

Yes, we specialize in custom formulation development tailored to meet the specific requirements of our clients. We work closely with our clients to understand their needs and develop formulations that align with their therapeutic goals and regulatory requirements.

4. What is involved in pre-formulation studies?

Pre-formulation studies involve assessing the solubility, stability, and compatibility of the API with various solvents and excipients. This step is crucial for identifying the most suitable formulation approach and ensuring the stability and efficacy of the final product.

5. How do you ensure the stability of injectable formulations?

We conduct extensive stability studies under different conditions to determine the optimal formulation that maintains API integrity. We also use stabilizers, antioxidants, and appropriate pH and buffering systems to enhance stability.

6. What methods do you use for sterilization?

We employ rigorous sterility testing and aseptic processing to ensure that all injectable formulations are free from microbial contamination. We may also use terminal sterilization methods, such as autoclaving or gamma irradiation, as required.

7. How do you address compatibility issues with containers and delivery systems?

We evaluate the compatibility of the formulation with various container materials (e.g., glass, plastic) and delivery systems (e.g., syringes, vials) to prevent adverse interactions. This includes testing for leachables, extractables, and physical stability.

8. What are liposome and nanoparticle formulations?

Liposome formulations encapsulate APIs within lipid bilayers, enhancing bioavailability and providing targeted delivery. Nanoparticle formulations use tiny particles to improve solubility, stability, and controlled release of APIs. Both technologies offer advanced drug delivery solutions with improved therapeutic outcomes.

9. What are sustained release formulations?

Sustained release formulations, such as microspheres and depot injections, provide a controlled and prolonged release of the drug over an extended period. This reduces the frequency of administration and improves patient compliance, especially for chronic conditions.