Injectable Formulation Development

Advantages of Injections

Injectables or parenteral preparations are pharmaceutical products that are delivered subcutaneously, intramuscularly, or intravenously, bypassing the body's primary protective systems - the skin and mucous membranes. Parenteral preparations include solutions, suspensions, emulsions for injection or infusion, and powders for injection or infusion. Compared with oral and topical preparations, parenteral preparations have many advantages due to their unique route of administration, including:

• Quick onset of effect.
• Avoid the first-pass effect.
• Low doses.
• High accuracy.
• High bioavailability.

However, precisely because of the specific nature of the route of administration, the dispensing, development, and production of parenteral formulations are particularly complex and must meet more stringent compliance regulations to ensure patient safety.

Explore Our Injectable 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 and innovative nanotechnology, our experienced scientists can help you solve any complex challenge.

Importantly, we work closely with our clients to ensure their needs and objectives are met while ensuring compliance with all regulatory requirements. Our team can provide a full range of services including drug screening, drug development, formulation design, production, and analysis.

CD Formulation provides the following injectable development services, including but not limited to:

• Injectable Solution Formulation Development

An injectable solution formulation is a liquid preparation that is intended for injection into the body for therapeutic purposes. These formulations are typically sterile and contain active pharmaceutical ingredients (APIs) along with other excipients such as solvents, stabilizers, and pH adjusters.

• Injectable Suspension Emulsion Formulation Development

An injectable suspension emulsion formulation is a type of medication that combines suspended particles with an emulsion to create a stable suspension that can be injected into the body. This formulation typically consists of a drug in solid form suspended in a liquid emulsion, which helps to ensure consistent dosing and distribution of the drug throughout the body.

• Injectable Nanoparticle Formulation Development

Injectable nanoparticle formulations are a type of drug delivery system that utilizes nanoparticles to deliver drugs efficiently and effectively within the body through injection. These formulations typically consist of small particles with diameters ranging from 1 to 100 nanometers, which can encapsulate or be conjugated with various drugs or therapeutic agents.

Our Expertise for Injectable Formulation Development

• Characterization of drug substances.
• Solubility enhancement studies, including pH testing, determination of solvents and co-solvents, and various excipient screening.

• PH test: Determine the most suitable pH of the target compound by adjusting the pH value of the solution and observing changes in solubility.
• Determination of solvents and co-solvents: Once the pH range is determined and a buffer is selected, further screening of solvents or co-solvents occurs (if required).
• Excipient screening and optimization: according to the above results, various excipients are further screened to enhance solubility or stability, usually including surfactants and solubilizers. this may include comparing the effects of different excipients on the solubility of the target substance through experiments.

• Formulation development, including qualitative and quantitative ingredient selection and optimization, process development, and analytical method development and validation.
• Stability studies, including conventional stability according to ICH, freeze-thaw and thermal cycle stability, photostability studies, reconstitution and dilution stability, etc.
• Manufacturing process development, including studying packaging material compatibility and evaluating various sterilization technologies and their impact on the product.
• Scale up from lab to pilot to commercialization.
• Analytical method transfer.

Why Choose CD Formulation for Injectable 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 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.