Selecting the optimal route of administration and formulation for a drug is crucial to ensure its clinical and commercial success. As pharmaceutical companies face competitive challenges from generic-drug incursion and reduced R&D productivity from their pipelines, strategies for more efficiently bringing drugs to market and for managing the product life cycle of new and existing drug products is vital.
IMAGE COURTESY OF CATALENT PHARMA SOLUTIONS
Formulation scientists are important participants in realizing these goals. To gain a better understanding of the technical challenges and solutions in drug delivery, Pharmaceutical Technology gained feedback through an industry survey, the Catalent–Pharmaceutical Technology Landscape Drug Delivery Survey. The survey examined key issues in formulation development and drug delivery overall and for oral product forms specifically (1). The survey showed that bioavailability and solubility were top technical concerns and that partnering strategies were important approaches for addressing technical challenges and concerns in resource allocation.
The survey showed that decisions on the route of administration are made early in the drug-development process. Once a route of administration has been decided, formulation scientists face a myriad of issues. Chief among them is the overall safety of the drug product. More than three-fourths of respondents regard safety as "very significant" and 17% regard it as "significant" (see Figure 1). Developing the appropriate therapeutic and delivery profile was the second leading challenge. Almost 91% of respondents identified developing the appropriate therapeutic and delivery profile as "very significant" or "significant" (see Figure 1). Other key findings from the survey (see Figure 1) showed:
Figure 1: How would you evaluate the following challenges when developing a drug formulation?
- 89% of respondents regarded bioavailability as "very significant" or "significant"
- 86% said solubility was a "very significant" or "significant" challenge in formulation development.
The survey also asked respondents what their chief concerns were in drug development. Key findings (see Figure 2) showed that:
Figure 2: What are your chief concerns when encountering challenges in drug development?
- Costs and budgetary concerns was the number one concern, with 73% of respondents identifying it as such
- 63% cited project delays as a chief concern
- 50% cited limited time for formulation development as a key challenge.
Addressing the challenges
How do companies address these challenges? Partnerships in various forms were identified as important tools. Key findings from the survey (see Figure 3) showed:
Figure 3: Which of the following has your company done to solve drug delivery and formulation challenges?
- 51% of respondents have used third-party providers of formulation technologies/development
- 50% have formed partnerships with academia
- 38% have worked with a drug-development or drug-delivery provider
- 27% have accessed a network of contract partners (see Figure 3).
Increasing R&D internally also was another popular option, with more than half of respondents using this strategy. A cross-functional approach, applied both externally and internally, was also a popular choice. Forty percent of respondents said they have used open collaboration and brainstorm sessions as a way to resolve challenges in drug delivery and formulation (see Figure 3).