The Birth of Blister Packaging

There is a great deal of discussion as to what was the first pharmaceutical blister package. Part of this controversy depends on one’s definition of a blister package. Blister packaging consists of several components that interact to accomplish the packaging of an oral solid dose medicine: the design of the blister and blister card, the materials that are used for the cavity or pocket and lidding, and the machines and tools that form the cavity or pocket, fill the product, and seal the lidding film to the blister. One key element: how does one get the medicine out of the blister. Indeed, that element influences the answer as to what was the first pharmaceutical blister package.

Were there pharmaceutical blister packages

before The Pill?

It is common to link the beginnings of pharmaceutical blister packaging with the launching of contraceptives in the early 1960s. In fact there is at least one other claimant to the title of the first blister package used in the pharmaceutical industry that predate the global launch of oral contraceptives. Melabon was packaged in a peel-off blister before contraceptives were packaged in blisters. However, if one defines pharmaceutical blister packages as Push-Through-Packaging (PTP) blisters, then Melabon does not qualify and it is the blister calendar pack, linked to oral contraceptives — “The Pill,” that hold the title of the first blister package. In order to fully understand pharmaceutical blister packaging, a little background on the development of The Pill is helpful.

The Pill and the Birth of PTP Blister Packaging

In 1939 Russell Earl Marker, an American chemist who developed the octane rating system for Ethyl Corporation, successfully made synthetic progesterone from chemical constituents found in Mexican yams in a process known as Marker degradation. Marker further discovered that he could use a giant Mexican yam as a starting substrate for the process. The use of Mexican yams eventually allowed Marker to undercut competing methods pioneered by Percy Julian using soy beans as a starting substrate.In 1944, Marker cofounded Syntex with two partners in Mexico City. He left the company a year later. Syntex broke the monopoly of European pharmaceutical companies on steroid hormones. The price of progesterone fell almost 200 fold over the next eight years. Chemists Carl Djerassi, Luis Miramontes, and George Rosenkranz at Syntex in Mexico City synthesized the first orally highly active progestin, norethindrone, in 1951. Syntex then began to look for partners to assist developing and marketing a contraceptive.In 1952 Frank Colton, chief chemist at G.D. Searle, independently synthesized the orally highly active progestins norethynodrel (an isomer of norethindrone), in 1952, and norethandrolone in 1953. Working with Dr. John Rock he formulated Searle’s product, Enovid, which launched first in the US and was packaged in a dark amber glass bottle. Enovid 10 mg was approved by the FDA for the treatment of menstrual disorders on June 10, 1957. Enovid 10 mg was approved by the agency for contraception on June 23, 1960. Enovid 5 mg was approved on February 15, 1961.The pharmaceutical industry began to perceive the huge potential market for The Pill, and 13 major drug companies (nine of them American) developed their own versions of oral contraceptives. Ortho Novum, Syntex and Parke Davis were the next U.S. companies to enter the market. In Europe two key players were Schering AG (Germany) and Organon (The Netherlands).In 1962, David P. Wagner was granted U.S. patent number 3,143,207 for the first oral contraceptive pill dispenser. He designed the dispenser to be the size of a makeup compact, so women could carry it discreetly in their purses. He spent the next decade litigating pharmaceutical companies to receive royalty/licensing fees for his patented design.

As contraceptives gained popularity the limitations of a bottle in assisting women to take contraceptives at the correct time became painfully clear and the impetus for the development of blister packages (the calendar pack). Three blister packages for contraceptives entered the market at about the same time: Organon’s Lyndiol, Schering AG’s Anovlar, and Ortho’s Novum. While it is unclear as to the exact dates these packages entered the market, Hassia’s machine (used by Schering) entered first, followed by Höfliger & Karg’s.

Timelines and pictures of early packaging as well as a transcript of the movie The Pill (produced as part of The American Experience) can be found at PBS’s site.

Schering AG & Anovlar

In 1961 Schering AG (now Bayer Schering Healthcare) received approval to market the first oral contraceptive in Europe under the brand name Anovlar® – initially sold in West Germany and later that year in Australia. The original packaging for Anovlar® was a strip pack, presumably made using HASSIA equipment.The Interpack Show in 1963 included the exhibition of a HASSIA VA-2 that ran the calendar blisters for Schering’s Anovlar® 21. The designer for this blister was Kurt Walter.Calendar blister pack for Schering AG’s Anovlar® 21.Schering AG contends that “Anovlar® 21 was the first drug to be offered in a modern type calendar pack invented by Schering.” It is pioneering packaging that along with Organon’s Lyndiol and Ortho Novum not only assured safe and efficacious medicine reached the patient but helped women adhere to the treatment plan – laying the foundations for what today is known as compliance packaging.

Organon And Lyndiol

In 1962, Organon Laboratories in Holland began development of Lyndiol®, a birth control pill administered on a 22-tablet regimen. Unlike the “three weeks on, one week off” system, Organon reasoned that “maximum patient reliability” was achieved when each new cycle of tablets began and ended on the same day of the week. If the last tablet was taken on a Friday, the first tablet from the next package would be taken the next Friday.Organon worked with Höfling & Karg to develop enhanced packaging for their oral contraceptive. The machine to package this began running in 1964.

Ortho-Novum 10 & Ortho-Novum 2

With 1.2 million American women on the Pill, Searle’s corner on the Pill market comes to an end. By 1962, Johnson & Johnson’s Ortho division introduced Syntex’s norethindrone product as a component of its birth control pill Ortho Novum.Ortho’s Dialpak was a remarkable change in packaging and a first in compliance packs. They used this package to differentiate their product from that of G.D. Searle. This went against the thinking of many pharmaceutical companies at that time. Packaging at the time was noted for its “numbing sameness.” It was the compliance feature of the DialPak that not only improved patient compliance but increased Ortho sales – a major development.However, David Wagner contended that this design, even today so associated with Ortho, was covered by his patent. In December of 1964 Ortho agreed to pay Wagner $10,000 in return for his agreement not to sue them.

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