Multi-dose formulations

A liquid formulation is usually comprised of a buffering agent, a stabilizer (which may also serve as a tonicity agent), a surfactant, and an anti-oxidant when protein oxidation is significant. Chelating agents are employed when metal ion catalyzed reactions predominate. A preservative may be included when a multi-dose formulation is desired. 

Preservative For multi-dose formulations only Provides protection against microbial growth in formulation E.g., benzyl alcohol For multi-dose formulations only Provides protection against microbial growth in formulation Is usually included in the reconstitution diluent (e.g., BWFI)... 

Preservative availability may be appreciably reduced by interaction with packaging materials. Examples include the permeation of phenolic preservatives into the rubber wads and teats of multi-dose injection or eye-drop containers and by their interaction with flexible nylon tubes for creams. Quaternary ammonium preservative levels in formulations have been significantly reduced by adsorption onto the surfaces of plastic and glass containers. Volatile preservatives such as chloroform are so readily lost by the routine opening and closing of containers that their usefulness is somewhat restricted to preservation of medicines in sealed, impervious containers during storage, with quite short use lives once opened. 

Powder container. Dry powder inhalers may contain the dry powder formulation in many different forms. The first DPI, the Spinhaler contained single doses in capsules. Other systems, like the Diskus or Diskhaler may contain the metered dose in blisters, whereas systems like the Turbohaler , or Novolizer , have multi-dose containers. 

Res ervoir/multi dose Active (powered devices) Improved formulations... 

Lopinavir and ritonavir are co-formulated as both Kaletra soft gelatin capsules and Kaletra oral solution. Kaletra fixed-dose combination oral solution contains 80 mg/mL of lopinavir and 20 mg/mL of ritonavir solubilized in propylene glycol, 42% ethanol, water, glycerin, cremophor RH 40 and peppermint oil. Kaletra oral solution is packaged in a 160-mL multi-dose container and should be stored refrigerated at 2-8°C or at room temperature for no more than two months. Kaletra oral solution has been available in the UK since 2001 and is also available in the USA. 

Microbiological preservatives and/or antioxidants may be necessary, especially if a multi-dose product is envisaged, or the oil used in the formulation is contaminated with peroxide. Care must be taken with both types of additive, as it is often the case that it partitions between the two phases and some of the required activity is lost. Activity may be also lost if there is incompatibility with other excipients, or there is adsorption onto the container/closure system. The choice of either component must therefore be checked thoroughly by effectiveness testing of the final product during the pharmaceutical development process. 

It is preferable to formulate ophthalmic nanoemulsions devoid of preservative agents and fill them in sterile single dose packaging units to prevent potential contamination due to repeated use of multi-dose packaging. ... 

Bioassay wt = wind tunnel, f = field traps. Other issues chem = pheromone chemistry, mult = multi-species lures, cr = cross attraction, seas = seasonal patterns, tp = trapping parameters such as height, type, pheromone dose, pheromone formulation/aging, or host-related synergist, wh = warehouse environment. 

Artesunate is a water-soluble hemisuccinate derivative, available in parenteral and oral formulations. The parenteral drug is dispensed as powdered artesunic acid. Neutral aqueous solutions are unstable. Artesunate is effective by the intravenous, intramuscular, and oral routes in a dose of 10 mg/kg given for 5-7 days. The combination with mefloquine is very effective even against highly multi-resistant strains of Plasmodium falciparum, the combination must be given for at least 3 days. 

For the purposes of this sub-section, a microdose product is a solid dosage form containing 5 mg or less of an active ingredient per unit dose of the product multi-vitamin, multi-vitamin and trace mineral unscheduled herbal and homeopathic formulations excepted. 

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