4 Tips To Leverage Your Ingredient Supplier For Faster Formulation
We all know that pharmaceutical drug development is a long and expensive process. When companies pursue the same market, a company that is ahead by a week or even days may end up getting the first approval. Research also shows that the early mover, unless the alternative is significantly better, tends to enjoy the vast majority of the market share. Arguably, there is a race between the formulation teams to advance their projects to clinical stages. In such scenarios, formulation scientists are under pressure to deliver drug formulations within tight timelines.
Hence, speed to formulation plays a critical role in recouping the investment for a new drug. This is particularly true for 505(b)(2) projects. Formulation scientists can leverage the ingredient suppliers, including the excipient makers, in the following four ways to improve the speed of formulation.
Tip 1: Leverage Ingredient Suppliers’ Molecular Modeling Groups
Ingredient suppliers come in several shapes and sizes. The following are some segments of ingredient suppliers that formulation scientists should be aware of:
- Commodity suppliers: These suppliers focus on selling large-volume commodity excipients. An example of this category would be fillers. These suppliers tend to focus on volume and cost-effectiveness. They may not have a significant material scientist team.
- Specialty suppliers: These suppliers focus on complex and unique formulation challenges. An example of this category would be “permeation enhancers.” These suppliers tend to have a strong application development group, but not all of them will have a materials specialist group.
- Powerhouses: These are suppliers that provide a broad spectrum of ingredients, including large-volume commodity ingredients and specialty excipients. Such suppliers have a strong application development group and a material scientist and analytical group.
Many ingredient suppliers have an experienced analytical group and material scientist group, and formulation scientists should reach out and leverage that expertise. While the formulation scientist and their company will have expertise in the areas of formulation development, when it comes to core chemistry such as polymer chemistry, the ingredient suppliers tend to have broader and deeper expertise. For example, many of these ingredient suppliers have a molecular modeling group that can help formulation scientists predict the chemical compatibility of ingredients in formulation. By doing so, a formulation scientist can minimize the trial and error involved in understanding the compatibility.
Tip 2: Request A Starting Formulation From The Ingredient Supplier
Many, if not all, ingredient suppliers have a formulation lab. Many formulation scientists do not realize that they can engage the ingredient suppliers by requesting a starting formulation. Of course, a non-disclosure agreement (NDA) needs to be signed between parties but it’s not unusual in the industry to sign NDAs. In some cases, these services are based on AI/ML that provides starting formulation suggestions immediately, and in some cases it’s a combination of machine models and manual formulations. Below are some examples of industry ingredient suppliers that provide a starting formulation service:
- ZoomLab: This service from BASF uses advanced algorithms to eliminate time- and cost-consuming trial and error work by predicting the most effective excipients to match a given active pharmaceutical ingredient.
- Quadrant 2: This service from ThermoFisher predicts the most optimal solubility enhancement technology and excipient combination to meet your clinical and business objectives, at the earliest stages of development.
- FastER: This service from Eastman uses artificial intelligence to suggest a starting coating formulation for sustained release. Formulation scientists do not have to start from scratch.
- HyperStart: This service from Colorcon provides a starting formulation suggestion.
The above is not an exhaustive list of ingredient suppliers that can provide starting formulation suggestions. Not many formulators are aware of such services.
Tip 3: Request Assistance With Feasibility Studies
One of the very first things a formulation scientist does in developing a new formulation is perform compatibility studies. While these studies don’t have to be sophisticated from a scientific standpoint, they take time to perform. A typical scientist works on one to three formulation projects each year and is very time constrained. While compatibility studies may not be studies of a highly technical nature, they are essential in drug formulation. In such cases, formulators can request the ingredient supplier to perform a compatibility/feasibility study. These studies often do not require a very deep level of formulation/application knowledge. Many ingredient suppliers have lab capabilities and can perform these feasibility studies for formulation scientists. If a drug has six to 10 components, excluding the API, asking the ingredient supplier to perform feasibility studies could save weeks of time for the formulation scientist.
Tip 4: Establish Joint Formulation Development
What many formulation scientists do not realize is that many ingredient suppliers have formulation labs and, importantly, formulation scientists. Formulation scientists do not have to interact only with the ingredient supplier’s salesperson to procure material or samples. Formulation scientists can work closely with an ingredient supplier’s formulation lab and formulation scientist. Usually, ingredient suppliers’ formulation scientists have a pharmaceutical formulation background or a strong material science background with experience in the pharma industry.
I have witnessed several examples where formulation scientists from the material suppliers helped the innovator’s formulation scientist to accelerate the formulation development. In one example, a formulation scientist of a major pharma company based in North America struggled for several weeks to find an optimal taste masking coating formulation. The scientist, after implementing an NDA, shared the API with the coating excipient supplier and was able to get to an optimal formulation within a week. While it might be unsettling to share the details of the API and formulation of a development project, material suppliers understand the sensitivity and work closely with pharma customers to maintain their secrecy. Often, the expertise of the material supplier’s formulation development lab is not known to the formulation scientists in a pharma company and the material supplier’s expertise is underutilized. But by working jointly with material suppliers to develop the formulation, formulation scientists can greatly accelerate their development timelines. In many cases, the formulation scientist will also get introduced to chemistries that she/he wouldn’t have otherwise considered and learn new ways of formulating.
Material suppliers in the pharma industry have significant capabilities. They understand the importance of secrecy and take it seriously so as not to undermine their brand and existence in the industry, with its long buying cycle. Formulation scientists should consider entering into NDAs with material suppliers and consider one or more of the above four tips to accelerate their timelines for formulation development.
About The Author:
Rajendran (Raj) Arunagiri has been in the pharma industry for a decade and has successfully developed and launched a new excipient. He is a co-author of technical articles and is an invited speaker at conferences focused on excipients and drug delivery. Arunagiri welcomes you to reach out to him for questions, comments, and collaboration ideas at raj.gceb@gmail.com.