Single dose containers

Tamper-resistant packaging Light-resistant container Well-closed container Tight container Hermetic container Single-unit container Single-dose container Unit-dose container Unit-of-use container Multiple-use container... 

Gels, depending on their application, contain either a hydrophilic or lipophilic liquids gelled by a suitable agent. They are often supplied in a single dose container or provided with an appropriate applicator to aid insertion... 

High-risk drug heparin Use only single-dose containers Standardize concentration and use premixed solutions Store separately from insulin ... 

H. Franke, P. Hencken, G. Ross, and J. Krueter. Influence of volatile rubber stopper components on the clearness of parenteral antibiotics stored in multiple or single dose containers after reconstitution with water. Eur. J. Pharm. Biopharm. 40(6) 379-387, 1994. 

Sterile water for injection USP Distillation or reverse osmosis Yes Same as WFI single-dose containers also used to reconstitute sterile solids and dilute sterile solutions... 

The second type of container is the single-dose container. This container should contain a quantity designed for a single-parenteral preparation (not to exceed 1 L) and should contain a suitable antimicrobial additive. Larger packaging volumes may be used for compounds designed for use with hemofiltration, dialysis, or parenteral nutrition. 

Currently, the best way is to use single dose contained in a folded paper (in community pharmacy) or sachets filled with the same accuracy as a tablet or capsule by a fully automatic machine. The sachet is made of paper, aluminum, and/or complex mixtures that are a combination of aluminum and plastic substances. 

Miro N. Controlled multicenter study on chronic suppurative otitis media treated with topical applications of ciprofloxacin 0.2% solution in single-dose containers or combination of polymyxin B, neomycin, and hydrocortisone suspension. Otolaryngol Head Neck Surg 2000 123(5) 617-23. 

Sterile water for Preserve in single-dose containers, preferably... 

In addition, it is not clear why the USP 27-NF 22 does not have the same restriction for the single-dose container, which is designed for drugs intended for... 

Bottle Injection syringe Single dose container... 

Cough Syrup A common brand of cough syrup comes in a 4-fluid ounce bottle. The active ingredient in the cough syrup is dextromethorphan. For an adult, the standard dose is 2 teaspoons, and a single dose contains 20.0 mg of dextromethorphan. Using the relationships,... 

For preparations in single-dose containers uniformity of mass (solutions) or uniformity of content)... 

Preparations for application to the injured ear, particularly when the eardrum is perforated, or prior to surgery are sterile, free from antimicrobial preservatives and supplied in single-dose containers. 

Ear preparations are supplied in multidose or single-dose containers provided, if necessary, with a suitable... 

Ear drops that may, or should reach the middle ear are sterile aqueous solutions, with a preservative added when they are supplied in multidose containers. The monograph Ear Preparations of the Ph. Eur. states that ear drops that may or should reach the middle ear, should be sterile and free from antimicrobial preservatives. That sterility is required seems clear, as the solvent in ear drops intended for the middle ear is water, and the middle ear has little defence because of its low blood flow. When preservatives are not to be used, such ear drops should be supplied in single-dose containers, unless otherwise justified. 

The requirements for the packaging of sterile ear drops are the same as for eye drops. That is why they are supplied in similar bottles (see Sect. 24.4.2). These may contain at most 10 mL. Sterile aqueous ear drops may also be supplied in a single-dose container. Plastic materials should, preferably, be polyolefins, that means, polyethylene (PE) or polypropylene (PP) because these are free from harmful phthalates. 

Microbiological quality Sterility if applicable And for ear drops in single dose containers ... 

If eye drops do not contain antimicrobial preservatives (Tables 10.7 and 10.8) they are supplied in single-dose containers or in multidose bottles preventing microbial contamination of the content after opening. 

Eye lotions are defined as aqueous solutions. Thus active substances must be soluble at the concentration needed. Eye lotions must be sterile. According to Ph. Eur. eye lotions intended for use in surgical procedures or in first-aid treatment do not contain an antimicrobial preservative and are supplied in single-dose containers, see for example an eye lotion with iodinated povidone (Table 10.11). 

An example of an eye lotion prepared in pharmacies is a low volume antiseptic solution for eye surgery. The lotion is filled in sterile injection vials, polyethylene dropper bottles or other suitable single-dose containers. If eye lotions do not contain antimicrobial preservatives they must be supplied in single-dose containers too. 

After filling, sealing and sterilisation of single-dose containers (for example Redipac plastic mbes, see Sect. 24.4.2.6), the integrity of the container should be confirmed by... 

Rectal solutions, emulsions and suspensions are liquid preparations intended for rectal use in order to obtain a systemic or local effect, or they may be intended for diagnostic purposes. Rectal solutions, emulsions and suspensions are supplied in single-dose containers and contain one or more active substances dissolved or dispersed in water, glycerol or macrogols or other suitable solvents. Rectal solutions, emulsions and suspensions may contain excipients, for example to adjust the viscosity of the preparation, to adjust or stabilise the pH, to increase the solubility of the active substance(s) or to stabilise the preparation. These substances do not adversely affect the intended medical action or, at the concentrations used, cause undue local irritation (Ph. Etur.). 

The influence of particle size on the absorption rate from aqueous suspension enemas has probably never been investigated. Dissolution of the active substance is assumed to increase with decreasing particle size (see Sect. 29.2.1). For the requirements on particle size for a stable suspension enema reference is made to Sects. 29.2 and 29.3 as well as to Sect. 5.10 because of similarity with oral suspensions. A particle size of maximal 180 pm generally satisfies. Suspension stability is less important than for oral use since an enema is dispensed in single-dose containers. However,... 

Sterile vaginal solutions are packaged in a single-dose container that can be sterilised, for instance glass (preferably class I, eventually class II) or plastic (polypropylene). Preserved concentrates, intended to be diluted before use, are usually packaged in a container of glass (class III) or plastic (polypropylene, polyethylene) meant for multiple dosing. 

According to Ph. Eur. Preparations for irrigation are supplied in single-dose containers. , for all sterile irrigations and dialysis solutions, with the exception of the concentrated solutions for haemodialysis, the container and the closure... 

Unless otherwise stated, the uniformity of dosage units specification is not intended to apply to suspensions, emulsions or gels in single-dose containers intended for cutaneous administration. The test for content uniformity is not required for multivitamin and trace-element preparations. 

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