Timed-Release Excipients: A Marvel of Modern Science
Author - Paula Garcia Todd, Global Application Development & Innovation Leader, IFF Pharma Solutions
Excipients, though often underappreciated, play a key role in the success of pharmaceutical formulations. As a formulator, you need an excipient you can rely on—a precise facilitator to ensure the efficacy of your product.
Enter cellulosics: the unsung heroes of drug development. These natural polymers enhance drug delivery, improve tablet properties, and contribute to stability.
Cellulosics are used to make ingestible polymers that facilitate and modulate the dispersion of therapeutic ingredients into the human body.
Excipients are labeled “inactive ingredients” or “fillers.” Despite these unassuming designations, they are marvels of chemical science — highly specialized, well-tolerated by the body, infinitely varied, biodegradable, and essential to ensure the maximum efficacy of oral medications.
At IFF Pharma Solutions, we pride ourselves on our extensive expertise in cellulosic ingredients, a field in which we have over 75 years of experience. Our unparalleled legacy in polymer science, particularly in cellulosics, sets us apart in the industry. Our flagship products, METHOCEL™ (Hydroxypropyl-Methylcellulose – HPMC), ETHOCEL™ (Ethyl cellulose), and Avicel® (Microcrystalline Cellulose – MCC), offer formulators a wide array of possibilities for both controlled release and immediate release applications.
From Lab to Life: The Drug Development Journey
The journey of drug development is challenging. Researchers dedicate themselves to inventing new compounds, rigorously testing their effectiveness, fine-tuning formulations, and advancing through clinical trials to achieve regulatory approval. Their ultimate goal is to create a molecule that significantly enhances patients’ quality of life.
In the drug development process, the critical phase between Phase I and Phase II clinical trials is when developers pair their active ingredient with the most suitable excipients. This is where our Pharma Solutions team steps in, collaborating with formulators to select or customize the perfect polymer from our extensive range of options.
The primary goal for any formulator is to ensure that the active ingredient in a tablet or liquid form enters the body and reaches the therapeutic window at the most beneficial time, also maintaining the active ingredient in the body for the optimal duration to effectively treat the clinical condition. This is where our modulated release excipients come into play.
Our excipients, such as METHOCEL™, are designed to achieve and sustain controlled release. The cellulosic backbone of METHOCEL™ grades is substituted with targeted methoxyl and hydroxypropyl levels to optimize water solubility. Additionally, the molecular weight is tailored to allow for varying swelling potentials of the polymer. Pharmaceutical scientists incorporate METHOCEL™ with active ingredients, forming an interconnected polymer network that gradually swells to release the medicine over time.
Extensive Range of Product Options
Over decades, Pharma Solutions has built one of the most comprehensive portfolios of modified timing solutions including matrix formulations, multiparticulates, and osmotic pump tablets. By offering this diverse range of options, we empower formulators to systematically and efficiently identify the most complementary polymer for their needs.
Optimizing Solutions
In pharmaceutical science, a one-size-fits-all approach is simply not feasible. Each therapeutic solution requires meticulous design and pairing with excipients that best suit its unique purpose.
Some formulators have considered multiparticulates, but they failed to deliver the active ingredient as needed. By recommending a switch to an osmotic formulation, for instance, we can help them achieve the desired therapeutic window.
Sometimes, a pharma partner faces particularly challenging formulation requirements that standard products can’t meet. With decades of experience working with these polymers, we can methodically devise a solution that meets the formulator’s needs. This might involve fine-tuning particle size, refining a substitution, or altering the polymer’s molecular weight to fully harness its potential.
Through these interactions, we drive pharmaceutical innovation forward.
Serving a Meaningful Purpose
As a lifelong chemical engineer in the pharmaceutical industry, I firmly believe in the profound impact this field has on improving people’s lives. My passion lies in developing and applying excipients that enhance the effectiveness of therapeutic compounds in the body. Every day, I have the privilege of collaborating with customers and my Pharma Solutions teammates to achieve this goal.
Our excipients, though not widely known to the patient, play a crucial role in helping patients receive the best possible therapies, ultimately improving their quality of life. This is truly rewarding.
