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The major players in the push button dropper market include Virospack, The dropper Company, Carow Packaging Inc., Beauty Packaging, Lecospack, Silgan Dispensing’s, APG Pharma Packaging, Vapor Packaging LLC, Pacific Vial Manufacturing Inc., Pacific Vial Manufacturing Inc., and Remy & Geiser GmbH.

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(1)Dosage size. A single dose of 0.5 to 1.0 g is generally the maximum dose of a conventional oral dosage form, which is also applicable to OCR drugs. With the development of formulation technology, many of the currently marketed tablets have exceeded this limit. However, as an oral dosage form, the dose size cannot be increased indefinitely. For large doses of the drug, multiple tablets can be taken at a time to achieve an effective dose. In addition, for drugs with a low therapeutic index, it must be considered that taking too much dose may cause safety problems.

(2) PKa, degree of dissociation and water solubility. Most drugs that are absorbed by passive transport in the body are weak bases or weak acids. In general, non-dissociated, fat-soluble drugs readily pass through lipid biofilms. The pH of the gastrointestinal tract and the pKa of the drug directly affect the degree of dissociation of the drug in the gastrointestinal tract. Since OCR drugs generally require release of the drug in an environment where the pH of the gastrointestinal tract changes, it is important to understand the relationship between pK and the absorption environment, and the effect of pH on the drug release process must be studied.

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(3) Distribution coefficient. Drugs must be absorbed through various biofilms before they produce therapeutic effects in the body. The gastrointestinal epithelial cell membrane is a lipid membrane, and the partition coefficient of the drug determines whether it can effectively penetrate the biofilm. Drugs with a high partition coefficient are highly soluble in fat. These drugs can be concentrated in the lipid membrane of cells and usually stay in the body for a long time. It is difficult to pass a drug through a membrane with a small partition coefficient, and the bioavailability is generally poor. Maintaining an appropriate oil-water partition coefficient gives the desired amount of biofilm permeation.

(4) Stability. Oral drugs are subjected to both acid-base hydrolysis and enzymatic degradation in the gastrointestinal tract. For solid drugs, the degradation rate is slowed down. Therefore, for a drug having a stability problem, the preparation may be in a solid state or other administration routes may be selected.

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