Executive Summary

Lilly's Elanco Qualicaps division is turning to a double-banded gelatin seal; Warner-Lambert's Capsulgel is using a thermal sealing technique and a flattened capsule shape; and R. P. Scherer is relying on its sonic sealing technology. The three different approaches are being aggressively promoted as capsule protection moves in the wake of the second round of capsule tamperings in February and March. Lilly is touting its Quali-Seal double-banding process as a safety sealing machine permitting efficient manufacturing runs. According to publicity material from Lilly, "although technology to seal capsules with a band has been generally available, it would not allow capsule filling machines to run at practical speeds." Lilly maintains that "Quali-Seal is the first equipment to seal capsules at efficient manufacturing speeds." Lilly said its two bands of gelatin "provide a stronger bond than can be achieved with one thick seal." The result "is a bonding of the body and cap of the capsule, which makes it difficult, if not impossible, to separate the capsule without causing noticeable damage," the company stated. Lilly's Elanco Qualicaps Div. began development of the Quali-seal equipment in 1981. According to Lilly, some European and U.S. pharmaceutical companies have already purchased the Quali-seal technology. Lilly said it plans to begin phasing in the process for all its own capsule products, most of which are Rx products. Warner-Lambert's thermal sealing technique called Licaps, bonds the capsule halves together in a three-stage process that first involves contact with a water-alcohol solution. Warner-Lambert's Capsugel Div. also markets Coni-Snap Supro capsules, which are squat-shaped to reduce the surface area that can be gripped "so pulling apart the halves is nearly impossible without visibly damaging the capsule," Warner-Lambert said. Licaps has been marketed since 1984 and Coni-Snap Supro capsules since 1983. The company says the combination of the new shape and thermal seal "offers the best in state-of-the-art safety technology." W-L's new shape also appears to offer capsule marketers the chance to show consumeres a visible change in their products to help sell the resealing technique as a safety advantage. R. P. Scherer employs a Sonniseal welding machine in its capsule production process that seals capsules by sonic waves. Sterling, who purchased two of the machines in 1985, is the only other company to use the Sonniseal system. Scherer recently announced it was closing its Somerset, N.J. hardshell gelatin capsule manufacturing plant in mid-May, primarily because Johnson & Johnson decided to discontinue marketing Tylenol in two-piece hardshell capsules. The firm now has four hardshell capsule manufacturing plants in: Windsor, Ontario, Canada; West Germany; Argentina; and Brazil.