Injectable Solution Formulation Development
Inquiry
CD Formulation has extensive experience in injectable solution development, whether you are developing generic drugs or formulating new chemical entities, we can provide you with professional support and solutions. Our team has the experience and expertise to help you determine the best drug carriers, solvent systems, and stability options. Importantly, we can also provide you with long-acting injection formulation development services, including suspensions, emulsions, nanoformulations, etc., to help you achieve successful drug development and commercialization goals.
Advantages of Injectable Solution
Injectable solution can be injected subcutaneously, intramuscularly, or intravenously and it is the most basic and simple injection preparation. It is a drug dissolved in a solvent, usually water, to form an injectable liquid dosage form. Injectable solutions can be used to treat a variety of diseases and conditions such as infection, inflammation, pain, and other conditions that require drugs to reach the bloodstream quickly. Compared with injectable emulsions, suspensions, and injectable nanoformulations, Injectable solutions formulation development and manufacturing are easier and they are usually prepared under strict sterile conditions to ensure the effectiveness and safety of the drug. However, injectable solutions come with certain drawbacks, including the possibility of pain and discomfort during the injection process, high adverse reactions and side effects due to the drug being injected directly into the blood circulation, especially for patients who are allergic or sensitive to the drug.
Explore Our Injectable Solution Formulation Development Services
CD Formulation has a proven track record in developing injectables and our team of experts can provide comprehensive support throughout the development process of new injectable pharmaceuticals. Leveraging our unparalleled injectable formulation technology platform, our experienced scientists can help you solve any complex challenge.
For active pharmaceutical ingredients (APIs) with good water solubility and high bioavailability, our experts usually design them as injectable solution formulations for injection when rapid treatment is required.This form ensures that the drug enters the blood circulation system as quickly as possible, thereby exerting the best effect in a short period.
Workflow our injectable solution formulation development:
- Identify the APIs that will be included in the formulation. This may involve a literature review, consultation with experts, and experimental testing.
- Determine the desired concentration of each API in the final solution, taking into account stability, solubility, and potential interactions between the APIs.
- Select the appropriate excipients and solvents to ensure the stability and compatibility of the formulation. Excipients may include solubilizers, preservatives, pH adjusters, buffers, and antioxidants.
- Develop a preliminary formulation by mixing the APIs, excipients, and solvents in appropriate ratios. This may involve various techniques such as sonication, stirring, or homogenization.
- Conduct compatibility studies to assess the physical and chemical stability of the formulation over time. This may involve testing for pH changes, precipitation, degradation, and other indicators of instability.
- Optimize the formulation based on the results of the compatibility studies. This may involve adjusting the concentrations of the APIs and excipients, changing the ratio of components, or selecting alternative excipients.
- Validate the final formulation through additional stability studies, including accelerated stability testing under various storage conditions.
- Scale up from lab to pilot to commercialization.
Our Capabilities for Injectable Solution Formulation Development
- Aseptic preparation.
- Wide range of molecules:
- Small molecules (including peptides).
- Biological products (e.g., recombinant proteins, monoclonal antibodies).
- Liquid preparation in a vial.
- Scale up batches manufacturing.
- Commercial cGMP batch manufacturing.
- Process validation.
- Analysis method development and verification for APIs.
- Analytical method transfer.
- Technology transfer.
Why Choose CD Formulation for Injectable Solution Formulation Development?
- Expertise: A team of experienced formulators who have the knowledge and skills to develop injectable formulations and optimize the formulation to ensure stability, compatibility, and efficacy.
- Regulatory compliance: Has a strong understanding of regulatory requirements for injectable formulations and ensures that the formulation meets all regulatory standards and guidelines.
- Customized solution: Work closely with clients to develop customized formulations that meet their specific needs and requirements to ensure optimal drug delivery and bioavailability.
- Advanced technology: Utilize state-of-the-art technology and equipment, allowing for precise control over the formulation process, leading to consistent and reliable results.
- End-to-end capabilities: From pre-formulation research to production of clinical trial drugs.
If you are seeking professional injectable solution formulation development services, please contact our team and we will be happy to provide you with support and assistance. Let CD Formulation be your reliable partner in the drug development process.
References
- Thomas S, Mahendran S, Selvakumar R. FORMULATION AND EVALUATION OF AN INJECTABLE SOLUTION AS A DOSAGE FORM. JDDT. 2018, 8(5): 81-87.
- Kumar Maheshwari R, Indurkhya A. Formulation and evaluation of aceclofenac injection made by mixed hydrotropic solubilization technique. Iran J Pharm Res. 2010,9(3):233-42.
Please note: Our products and services are not intended to be used directly in diagnostic or therapeutic procedures.
Related Services