Innovation is the cornerstone of any industry, and Pharmaceutical Technology conducted a survey to determine the degree of, type of, and sources of innovation for pharmaceutical development and manufacturing. Key findings showed the level of innovation to be the highest in drug delivery, quality systems, and pharmaceutical analysis and the weakest in solid-dosage and small-molecule manufacturing. Respondents also said that quality by design (QbD) plays and will continue to play an important role in innovation, as will lean manufacturing and green chemistry.
Patricia Van Arnum
Level of innovation
The survey asked respondents to rate the level of innovation during the past year (see Figure 1). Respondents most frequently rated innovation high in drug delivery (24%), quality systems (21%), and pharmaceutical analysis (19%). Process development and manufacturing of biologic-based active pharmaceutical ingredients (APIs) and formulation development ranked in the middle. Fourteen percent of respondents rated innovation high in process development and manufacturing of biologic-based APIs, and 12% rated innovation high in formulation development.
Solid-dosage manufacturing, parenteral manufacturing, and process development and manufacturing of small molecules ranked fairly low. Only 6% of respondents said innovation was high in parenteral drug manufacturing, and 23% rated it as low. Only 10% said innovation was high in solid-dosage manufacturing, and 28% rated the level of innovation as low. Ten percent of respondents said innovation was high in process development for small molecules, and 9% said it was high for manufacturing of smallmolecule APIs. Eighteen percent said innovation was low in these areas.
Figure 1 Question: Rate the level of innovation during the past year for the following areas
Drug delivery and formulation
Nearly 64% of respondents ranked the level of innovation in drug delivery as either high or medium (see Figure 1). Looking at specific product forms, nearly 19% of respondents said innovation was high for respiratory (inhaled or nasal) delivery, making respiratory products the strongest product form for innovation in drug delivery. In contrast, only 12% of respondents rated innovation high for solid-dosage products, 7% did so for injectables, 4% for semisolids, and 3% for liquids.
The survey also examined the importance of innovation in formulation (see Figure 2). Respondents most frequently rated innovation very important in addressing the delivery of high-potency drugs (53%), poorly water-soluble drugs (52%), delivery of proteins and peptides (45%), and nanotechnology (37%).
Figure 2 Question: How would you rate the importance of innovation in addressing the following issues in formulation?
Innovation in delivering combination drugs, vaccines, and controlledrelease products also received fairly high marks. Roughly one-third of the respondents said that innovation was very important for controlled-release products. Nearly 31% of respondents said innovation for combination products was very important, and 27% said so for vaccine delivery (see Figure 2).
Capsules, tablets, and fast-melting products were areas in which respondents did not give innovation a priority. Nearly 22% of respondents said that innovation in capsule or tablet design was not important, and 12% said innovation for fastmelt release was not important.
Although the level of innovation for solid-dosage manufacturing was ranked lower than for other areas, respondents pointed to the need for ore innovation in this area. Nearly 10% ranked the level of innovation in solid-dosage manufacturing as high, 34% ranked it as medium, and nearly 28% as low (see Figure 1).
But respondents were interested in seeing more innovation in solid-dosage manufacturing. Nearly one-quarter of respondents said innovation was very important in the areas of coating, granulation, compaction, milling, and drying. More than one-third said innovation was somewhat important for these areas.