Formulations for In Vivo Studies
Getting the Recipe Right Early to Avoid Unexpected Results
Formulation screening is the process of evaluating different formulations of a drug or biologic in order to identify the optimal combination of ingredients, dosage form, and manufacturing process. This can include testing different excipients, altering the pH or salt form, or experimenting with different recipes. The main goal of formulation screening is to find the combination that results in a stable, effective and safe final product. Formulations can include solutions and suspensions among others, and the chosen formulation can have a significant impact on the final stability, bioavailability and efficacy, as well as the dose route and administration schedule.  Formulation screening services mark a crucial point in the drug development process for our clients. This is when we begin collaborating with you the client to create the final "recipe" of your drug. Every step of the process is important, but getting the details on this initial stage is vital, because it is the base layer upon which the rest of your in-vivo research will be built. If we don’t pay attention to every detail during this early stage, there is the potential for so many later elements in the development to just… fall apart.

Once we have the API, a formulations guide, and having assessed the client’s requirements, initial decisions that must be made include, what type of vehicle is appropriate – meaning, is it going to be a suspension or a solution? Is it going to be an oral (PO) or intravenous (IV) dose? For example, if it’s an IV, what type of filter should be used? These are some critical questions for us to ask and establish correct answers early on, as they determine immediate courses of action we take toward the recipe and dosing process, and this has a big impact on the downstream direction in-vivo testing will take for your drug development.

With that in mind, it becomes extremely important that we help our clients make the right decisions every time.

Often we may have a client who comes to us with a recipe they have been using, but it is just not producing the results they are expecting. In such situations, it falls on us to identify the specific aspect of the recipe that is causing inadequate results, or which steps of the recipe need to be modified. For instance, we have had clients submit a recipe that calls for heating to 40°C before dissolving, however our experienced formulators have helped determine that a higher temperature is necessary. Other examples include making slight adjustments to the pH to achieve solubility. This is where Attentive's meticulousness and excellent communication skills differentiate us from our competitors. Every moment counts and every detail matters during these stages, and Attentive will make sure you have the answers you need as quickly as possible, so you can continue with confidence as you move ahead with addressing other challenges of development.

“Quote from Nou (formulations Lead) I have worked for larger CROs in the past, and I can tell you that this is NOT the case with the “big guys” in the industry. One-on-one direct lines of communication like the ones you will find at Attentive are unique, and they make a world of difference when it comes to the efficiency and speed with which we can offer feedback and results to our clients.”

Additionally, the nature of how Attentive is setup within our own space and the way we maintain our client relationships is also key to successful screening results. As an example, our clients have direct contact with formulations, meaning that instead of working through a third party or transferring our communications through an additional person, you can actually go directly to them and work directly with their formulators – and, visa versa, their formulators can contact you.

“I am currently working with Nou on several projects related to formulation preparation of dosage forms, mainly oral liquids.  I was impressed with her knowledge and hands-on experience from the first time we met. She was able to scale up our small preparation standard operating procedure for making a small quantity of our dosage form into an appropriate volume for our in-vivo studies. And successfully prepared 20+ formulations, which all passed the analysis test.”

~Current Client

Getting your formulations right is too important to leave them in the hands of anyone but Attentive Science. So many things can go wrong at this stage if done incorrectly… and if you get it wrong during this stage, the rest of your drug development will only produce the wrong results, so everything after formulations will be a waste of time until you come back here to the beginning to get it right.

Call or email us, and we will support you with your formulation requirements.

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