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Dosage forms- Injections-Definitions

  • INJECTION, SUSPENSION
A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
  • INJECTION, SUSPENSION, SONICATED
A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. In addition, the product is sonicated while a gas is bubbled through the suspension, and this results in the formation of microspheres by the solid particles.
  • INJECTION, SUSPENSION, LIPOSOMAL
A liquid preparation, suitable for injection, which consists of an oil phase dispersed throughout an aqueous phase in such a manner that liposomes (a lipid bilayer vesicle ususally composed of phospholipids which is used to encapsulate an active drug substance, either within a lipid bilayer or in an aqueous space) are formed.

  • INJECTION, SUSPENSION, EXTENDED RELEASE
A sterile preparation intended for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).
  • INJECTION
A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
  • INJECTION, EMULSION
An emulsion, a two-phase system in which one liquid is dispersed throughout another liquid in the form of small droplets, consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.
  • INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
A dosage form intended for the solution prepared by lyophilization (“freeze drying”), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections; .
  • INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
A liquid preparation, intended for parenteral use, that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization (“freeze drying”), a process which involves the removal of water from products in the frozen state at extremely low pressures.
  • INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE
A sterile freeze dried preparation intended for reconstitution to form a suspension for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution).
  • INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION
A sterile freeze dried preparation intended for reconstitution for parenteral use which has been formulated in a manner that would allow liposomes (a lipid bilayer vesicle ususally composed of phospholipids which is used to encapsulate an active drug substance, either within a lipid bilayer or in an aqueous space) to be formed upon reconstitution.
  • INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE
A sterile freeze dried preparation intended for reconstitution for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution).
  • INJECTION, POWDER, FOR SUSPENSION
A sterile preparation intended for reconstitution to form a suspension for parenteral use.
  • INJECTION, POWDER, FOR SOLUTION
A sterile preparation intended for reconstitution to form a solution for parenteral use.
  • INJECTION, SOLUTION
A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
  • INJECTION, SOLUTION, CONCENTRATE
A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
  • INSERT, EXTENDED RELEASE
A specially formulated and shaped solid preparation (e.g., ring, tablet, or stick) intended to be placed in the vagina by special inserters, where the medication is released, generally for localized effects; the extended release preparation is designed to allow a reduction in dosing frequency.


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