A Prototype Intelligent Hybrid System for Hard Gelatin Capsule Formulation Development

the pharmaceutical industry’s need to maintain its economic incentive to develop new drugs, have required that the industry increase speed to market and reduce the number of failures and overall cost of new drug development. This need has made it imperative for the industry to use efficient, systematic approaches to both drug discovery and formulation design. To accelerate drug discovery, scientists now use highthroughput biological screens and combinatorial chemistry that lead to the rapid discovery and identification of numerous potentially useful drugs. Given this high rate of discovery, drug delivery system development for these drug substances—rather than drug discovery itself—is likely to be the rate-limiting step in getting new drugs to market. Drug substances must be formulated into dosage forms to be practical. These dosage forms must meet the prescribed drug delivery requirements as well as be manufacturable. These requirements present formulation scientists with a complex array of variables. The days of the traditional trial-and-error approach to formulation development based on individual formulators’ experiences are gone, and pharmaceutical scientists must adopt efficient, systematic approaches to keep pace with both the numbers and complexity of new therapeutic substances. Indeed, the challenge to drug delivery has grown significantly in recent years as new, more-potent compounds are being developed that often lack the solubility and permeability characteristics needed for effective oral drug delivery. Capsules occupy a central role in drug development. Because they are perceived to be simpler to manufacture than other oral dosage forms and because of the need to shorten the overall development period, capsules are frequently the first dosage form considered for any orally administered drug, often with the expectation that a compressed tablet will be the final marketed form. Among solid dosage forms, the capsule is second only to the compressed tablet in terms of frequency of use. Given the unique advantages of this dosage form, the popularity of the capsule should not be surprising. For instance, because the medication is contained within the capsule shell, the capsule provides a tasteless, odorless delivery system that doesn’t require a secondary coating step. Many patients find that swallowing capsules is easier than swallowing tablets. Furthermore, several surveys have revealed a generally favorable consumer attitude toward