The concentration of the components in parenteral products may be expressed in various ways such as percentage weight/volume, weight per unit volume and millimoles per unit volume. Single-dose Preparations Single-dose preparations are defined as the volume of injection in a single-dose container sufficient to permit the withdrawal and administration of a nominal dose. Multiple-dose Preparations…
Ampoules are labeled by direct printing on the glass. For small-scale dispensing, a paper label is used and it should contain information such as the following: Preparations intended to be used as dialysis, hemofiltration or irrigation solutions should meet the standards for injections except that the label should bear a warning that the solution is…
Figure 8.3 shows the process flowchart of parenteral manufacture. Figure 8.3 Process Flow Chart of Parenteral Manufacture Figure 8.4 indicates the overview of the steps of manufacturing process of parenterals. Figure 8.4 Overview of Manufacturing Process of Parenterals Figure 8.5 shows the flow of materials through the parenteral unit. Figure 8.5 Material Flow in Parenteral Unit
Elastomeric closures or rubbers are commonly used for parenterals because of their compressibility and resealability properties. They can be easily penetrated by a hypodermic needle and the puncture reseals after the withdrawal of the needle. They are impermeable to water vapor and other gases. They reduce the particulate level or extractables in the preparation and…
Glass containers have been replaced to a greater extent with plastic containers as they are lightweight and stable against breakage. Nowadays, glass is used only for those products that are not compatible with plastic. Plastics are polymers that can be shaped when softened and then hardened to produce the desired shape and structure. Flexible containers…
Type I (Borosilicate Glass): This is commonly known as neutral glass. It has a high resistance to hydrolysis and can withstand autoclaving, weathering and solutions of pH up to 8. It can be used for all types of preparations and especially for analytical glass apparatus. Type II (Treated Soda Lime Glass): Containers may be treated with…
Containers for parenteral products are produced from one of the following three types of glasses or from one of a variety of plastic materials.
Apart from the ingredients discussed above, the other additives that are commonly included in the parenteral preparations are flocculating agents, surfactants, emulsifying agents, and suspending agents depending upon the formulation requirement.