초록 ▼

A method and apparatus for optimally performing dissolution testing of pharmaceutical dosage forms, agricultural products, and components of industrial products wherein the method uses dissolution profiles from a known drug dosage form, or product, as reference data for a predictive process; and the

A method and apparatus for optimally performing dissolution testing of pharmaceutical dosage forms, agricultural products, and components of industrial products wherein the method uses dissolution profiles from a known drug dosage form, or product, as reference data for a predictive process; and the apparatus is organized to carry out the method via both closed loop and open loop operating modes under the control of a central processor. An illustrative embodiment teaches the serial usage of the two operating modes in a single flow-through dissolution cell configuration to optimally predict the time course of in vivo bioavailability from in vitro dissolution measurements, while an alternate embodiment teaches the use of a plurality of dissolution cells and the simultaneous use of the closed and open loop operating modes to implement an Internal Standard capability. Additionally, an optimally adaptive capability is provided in the dissolution testing process via a random input modeling mode of operation.

대표청구항 ▼

Apparatus for the automated dissolution testing of products whose solubility and dissolution rate properties affect product performance comprising: (a) a dissolution cell having an input line, an output line, and a filtering chamber therebetween; (b) at least two reservoirs connected to said input l

Apparatus for the automated dissolution testing of products whose solubility and dissolution rate properties affect product performance comprising: (a) a dissolution cell having an input line, an output line, and a filtering chamber therebetween; (b) at least two reservoirs connected to said input line through a like number of media supply lines for providing dissolution media from said reservoirs to said filtering chamber; (c) first flow control means responsive to a first control signal and positioned in said input line for controlling the flow of dissolution media through said filtering chamber, and second flow control means responsive to a second control signal and positioned in at least one of said media supply lines for controlling the flow of dissolution media therethrough; (d) recirculating means including third flow control means responsive to a third control signal and connected to said input and output lines for controlling recirculatory flow therebetween; (e) system output means connected to said output line and containing means for measuring output parameters therein including a concentration parameter of particular constituents flowing therethrough, and for providing a time series of system output signals corresponding to said measured output parameters; (f) memory means for providing a time series of stored control signals to said apparatus; and (g) a multimode electronic control system having a separate feedback control channel for providing each of said first, second and third control signals, said control system connected to said first, second and third flow control means, and to said system output means, and using negative feedback circuitry in a first mode to form a difference error signal between said stored control signals and said system output signals for automatically determining said first, second and third control signals so as to continuously tend to minimize the value of said difference error signal, and further operative in a second mode for automatically providing said first, second and third control signals in the absence of said stored control signals.