What is formulation studies?

Formulation studies are a series of experiments that are conducted to develop a stable and effective drug product. The goal of formulation studies is to identify the right combination of ingredients, excipients, and manufacturing processes to produce a product that meets the desired specifications.

Why are formulation studies important?

Formulation studies are important because they can help to ensure the safety, efficacy, and stability of drug products. By identifying and addressing potential problems early in the development process, formulation studies can help to prevent costly and time-consuming product recalls.

What are the different types of formulation studies?

There are a variety of formulation studies that can be conducted, including preformulation studies, stability studies, in-use stability studies, and compatibility studies. The specific type of study depends on the drug product and its intended use.

What are the benefits of formulation studies?

The benefits of formulation studies include increased product safety and efficacy, reduced risk of product recalls, improved product performance, reduced development costs, and a shorter time to market.

How can I find a formulation studies company?

To find a formulation studies company, consider factors such as the company's experience, expertise, facilities, and accreditation by recognized organizations like the United States Pharmacopeia (USP). Research and contact companies that meet your criteria to discuss your specific needs.

Formulation Studies

Our pharmaceutical and Bio-Pharmaceutical Development services include formulation development for a wide range of molecules, including small chemical and large protein molecules such as enzymes, monoclonal antibodies, growth factors, complex glycoproteins, and novel recombinant constructs. Whether you need a standalone service or a comprehensive development program, we have the expertise to meet your needs.

In addition to our formulation development services, we also provide analytical chemistry laboratory and Pharmaceutical Laboratory testing services, including analytical method development and validation as part of our overall development services. Our analytical development services include Pharmaceutical Pre-Formulation and formulation studies, Lyophilization, drug product dissolution, and Stability studies, to determine the shelf life of the medicinal product.

We are committed to providing our customers with the highest quality services and support, and we welcome the opportunity to work with you on your next project. Be sure to visit our Analytical Development page for more information on the services we offer.

In addition, Synergy Bioscience can support your product development activities by offering the following studies:

Stress-degradation

Protein is subjected to stress conditions (e.g. oxidation, extreme pH, elevated temperature, freeze-thaw cycling, agitation) in order to identify product sensitivity to various stress conditions and to confirm that the selected assays are stability-indicating.

Preformulation

A variety of excipients and parameters are examined under accelerated conditions to identify those providing the greatest product stability

Formulation Selection

Several candidate formulations are examined under real-time and accelerated conditions, typically over a period of three months, to provide an optimized final formulation together with preliminary stability data

In-use Stability

Product stability is assessed in configurations to be used in a toxicology dose-ranging study or in the clinic

Material Compatibility

Product compatibility is assessed with materials used in candidate container closure systems or with materials used during manufacturing.

Cookie	Duration	Description
cookielawinfo-checkbox-analytics	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional	11 months	The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy	11 months	The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.