In recent years, the need to consistently place the patient at the center of development and manufacturing decisions has been key in the pharmaceutical industry. With immense global competition in the market, companies are keen to differentiate themselves from their competitors. This is particularly important for over-the-counter drugs, where patients are empowered to choose their own treatment. Consequently, whether developing new drug products or trying to extend the lifecycle of older formulations, consideration of the patient experience plays a significant role in decision making.

In this blog, Lubrizol Life Science Health (LLS Health) explores the meaning of patient centricity and the key considerations that pharmaceutical companies should bear in mind to ensure the successful development of a truly patient-centric drug product.

What patient centricity means today

Developing a patient-centric drug product means creating medicines that produce a positive experience for the end user. There are many factors that come into play, for example:

How will the product be administered?
How often does a patient need to administer the product?
How does the product taste or feel?
What are the potential side effects?

Nevertheless, developing drug products with an optimal experience is no easy task, as many of these factors present challenges. For example, oral solids are one of the easiest and most convenient forms of treatment that a patient can administer themselves, especially older patients with dexterity issues. However, orally administered drugs can cause gastrointestinal (GI) irritation and other side effects, such as diarrhea and nausea, when compared to drug products that utilize other delivery routes, such a topical.

It is therefore important to carefully balance these factors to optimize the consumer experience, while achieving the best treatment outcome and efficacy.

Overcoming patient-centric challenges

To distinguish a drug from similar available options, it is essential to offer other unique patient benefits. Addressing some of the challenges patients face can help differentiate a drug product, while also influencing patient preference.

Challenge 1: Inconvenient administration

Although oral drug administration offers many benefits, many patients find swallowing solid dose pills difficult, particularly children and the elderly. This can result in poor patient compliance: in a 2013 study by the European Journal of Clinical Pharmacology, 37% of adults were found to have difficulty swallowing pills, and 10% stopped taking the medication as a result. Developing a smaller pill with the same level of API can help overcome this issue, however this can be challenging. Since the API amount must generally remain the same, typically an excipient or excipients with a lower usage level are needed to reduce the oral tablet size.

Oral liquids can also be an alternative to hard-to-swallow oral tablets. However, oral liquids come with their own challenges, such as taste or the need to ”shake well before use.”

Shaking is often required to evenly distribute the API and other ingredients, as sedimentation commonly occurs while a product sits. Without adequate shaking, improper dosing can occur. Formulation techniques harnessing advanced excipients can ensure ingredients remain in permanent, stable suspension during storage, eliminating the possibility of inadequate dosing and the need for patients to remember to shake well before use.

Challenge 2: Unpleasant side effects

A common reason a patient will prefer the use of one drug over another is if they experience fewer side effects compared with alternatives. In cases where symptoms are mild, one study demonstrated that patients had a stronger preference for a less effective medication with fewer side effects as compared with a more effective medication with additional side effects¹.

As we mentioned above, traditional oral administration can sometimes cause irritation to the GI tract. Immediate release solutions can release inconsistent levels of drug over time, causing fluctuations that can result in serious problems such as toxicity or ineffective treatment². Using controlled release approaches can alleviate side effects by ensuring a consistent level of API over a prolonged period. Controlled release methods can be achieved through formulation, where excipients can be added to help regulate the rate of release.

Additionally, common side effects associated with orally administered drugs can sometimes be negated with the use of alternative routes of administration, such as topical dosage forms that can be applied directly to the site of action. Topical medications have the benefit of avoiding the first-pass metabolism of digestion as well as often having reduced levels of drug in the bloodstream as compared with other delivery systems, leading to decreased side effects³.

Challenge 3: Dosing frequency

Frequency of dosing is associated with patient compliance, with more patients forgetting to take multiple daily doses as compared with single daily doses. In one study, compliance for patients with a daily dosing schedule as compared with those with a dose three times a day was 79% and 38%, respectively⁴.

Immediate vs Extended Drug Release graph

Extended-release formulations, where the drug is released over an extended period in a controlled way, can reduce the frequency required for drug administration. These formulations have many advantages over others, including reducing the frequency of dosing and reducing the risk of adverse effects by making drug concentrations in the blood more consistent⁵.

When it comes to topical formulations, the use of mucoadhesive excipients can also reduce dosage frequency. These specific excipients help the drug adhere at the site of action, prolonging therapeutic effect without having to increase API levels, while also minimizing run-off of the drug product from the target site.

Find a partner focused on the patient

Failure to consistently take patient experiences into account in drug product development decisions may force consumers to look elsewhere for products that meet their needs. This task can be challenging, but by working with a partner that specializes in supplying patient-centric excipients and the formulation of such products, it is possible to instill patient-preferred characteristics in drug products.

LLS Health has more than 20 years of experience supporting its clients and providing excipients that impart patient-centric advantages. To find out more on how patients are driving differentiation in the pharmaceutical industry and how LLS Health can help, download our infographic or contact us.

Seyed-Hosseini M, Taylor J, Quest D. Discussing side effects of over-the-counter medicines: impact of adding percentage data. Int J Pharm Pract. 2010;18(5):275-281.
Thedrattanawong, C., Manaspon, C., & Nasongkla, N. (2018). Controlling the burst release of doxorubicin from polymeric depots via adjusting hydrophobic/hydrophilic properties. In Journal of Drug Delivery Science and Technology (Vol. 46, pp. 446–451). Elsevier BV.
Parfitt JR, Driman DK. Pathological effects of drugs on the gastrointestinal tract: a review. Hum Pathol. 2007 Apr;38(4):527-36.
Paes AH, Bakker A, Soe-Agnie CJ. Impact of dosage frequency on patient compliance. Diabetes Care. 1997;20(10):1512-1517. doi:10.2337/diacare.20.10.1512
Wheless, J. W., & Phelps, S. J. (2018). A Clinician's Guide to Oral Extended-Release Drug Delivery Systems in Epilepsy. The journal of pediatric pharmacology and therapeutics: JPPT: the official journal of PPAG, 23(4), 277–292. https://doi.org/10.5863/1551-6776-23.4.277

Addressing the Challenges of Patient-Centric Drug Development