Stability of stabilized nitroglycerin tablets in typical distribution and administration systems. 1975

B Dorsch, and R Shangraw

A study was undertaken to determine whether or not the present extreme restrictions on the packaging of nitroglycerin tablets are indeed necessary when dispensing the newer stabilized tablets. Baseline tests were conducted on two molded and two compressed sublingual nitroglycerin tablets to determine weight variation, content uniformity, average potency and friability. Stability tests included: (1) use test designed to simulate patient use from a single bottle of 100 tablets over a one-month period; (2) an open plate study wherein tablets were exposed to the atmosphere for 100 days; (3) strip packaging of tablets using foil-foil or foil-cello systems; (4) placement of tablets in medication cups for a seven-day period; (5) repackaging 30-tablet batches in a variety of common prescription containers. All brands of tablets retained potency during normal use when dispensed and stored in their original containers. However, one brand was superior to all others when placed under stress conditions such as open plate exposure. These tablets also retained labeled potency when exposed in a medication cup for a seven-day period, or when repackaged in either foil-foil or foil-cello strips, or when dispensed in a number of ordinary prescription containers. The study indicated that this brand of nitroglycerin tablets might be handled like any other solid dosage form in hospital distribution systems without endangering patient care. However, exceptions to present packaging restrictions must be cleared with the Food and Drug Administration.

UI MeSH Term Description Entries
D008510 Medication Systems, Hospital Overall systems, traditional or automated, to provide medication to patients in hospitals. Elements of the system are: handling the physician's order, transcription of the order by nurse and/or pharmacist, filling the medication order, transfer to the nursing unit, and administration to the patient. Hospital Drug Distribution Systems,Hospital Medication System,Hospital Medication Systems,Medication System, Hospital,Drug Distribution System, Hospital,Drug Distribution Systems, Hospital,Hospital Unit Dose Drug Distribution System,Hospital Unit Dose Drug Distribution Systems,System Hospital Medication,Systems, Medication Hospital,Hospital Medication, System,Hospital Medications, System,Hospital System, Medication,Hospital Systems, Medication,Medication Hospital System,Medication Hospital Systems,Medication, System Hospital,Medications, System Hospital,System Hospital Medications,System, Hospital Medication,System, Medication Hospital,Systems, Hospital Medication
D004349 Drug Packaging Containers, packaging, and packaging materials for drugs and BIOLOGICAL PRODUCTS. These include those in ampule, capsule, tablet, solution or other forms. Packaging includes immediate-containers, secondary-containers, and cartons. In the United States, such packaging is controlled under the Federal Food, Drug, and Cosmetic Act which also stipulates requirements for tamper-resistance and child-resistance. Similar laws govern use elsewhere. (From Code of Federal Regulations, 21 CFR 1 Section 210, 1993) DRUG LABELING is also available. Drug Containers and Closures,Packaging, Drug,Drug Containers,Container, Drug,Containers, Drug,Drug Container,Drug Packagings,Packagings, Drug
D004355 Drug Stability The chemical and physical integrity of a pharmaceutical product. Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D005996 Nitroglycerin A volatile vasodilator which relieves ANGINA PECTORIS by stimulating GUANYLATE CYCLASE and lowering cytosolic calcium. It is also sometimes used for TOCOLYSIS and explosives. Glyceryl Trinitrate,Anginine,Dynamite,Gilustenon,Nitrangin,Nitro-Bid,Nitro-Dur,Nitrocard,Nitroderm,Nitroderm TTS,Nitroglyn,Nitrol,Nitrolan,Nitrong,Nitrospan,Nitrostat,Perlinganit,Susadrin,Sustac,Sustak,Sustonit,Transderm Nitro,Tridil,Trinitrin,Trinitrolong,Nitro Bid,Nitro Dur,NitroBid,NitroDur,Trinitrate, Glyceryl
D012995 Solubility The ability of a substance to be dissolved, i.e. to form a solution with another substance. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed) Solubilities
D013607 Tablets Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed) Tablet
D013997 Time Factors Elements of limited time intervals, contributing to particular results or situations. Time Series,Factor, Time,Time Factor

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