摘要:
There is disclosed instrumentation for use in connection with one or more tablet presses of various types, and in particular rotary tablet presses, for virtually any reasonable combination and number of such tablet presses. Tablet formation information, in particular compression and ejection force information, tablet capping information and force information related to the time of occurrence of punch withdrawal is provided and processed by such instrumentation. This information is selectively applied to converting means which renders the selected information in a convenient data form for processing. Selection of the information may be made for example based on the need or desire to monitor a particular tablet press, tablet press station and/or individual tablet die/punch set combination. The selected information is processed by data processing means to provide output signals, including tablet press control signals, relating for example to the average and standard deviation of a pre-established number of consecutive tabletting events and determination of the frequency and number of abnormal tablet formations. The instrumentation may be employed to determine tabletting characteristics of pharmaceutical tablet granulations. Provision is also made for determining and isolating tablets failing to meet pre-established criteria.
摘要:
There is disclosed a method and apparatus for standardizing, in terms of a pre-established range of acceptable in vitro release and/or in vivo response, production of tabletted formulations which have a dependency on tablet hardness, through control of the maximum tabletting compression force developed by the tablet press employed, and for providing an individual momentary as well as permanent readout in digital form of the maximum compression force developed for each tabletting event. One or more tablets are compressed from a particular batch of formulation at selected different press compression force settings. These tablets are processed to derive data regarding in vitro release and/or in vivo response with a determination of an optimum value being made directly from or by interpolation of the resulting data. This optimum value is correlated to a press setting and the press is then set thereat for the tabletting of the bulk of the batch of formulation. Transducer means are appropriately mounted on the press to effect a signal output indicative of the compression force developed for each tabletting event. The transducer output is processed to derive only the true maximum developed compression force for each tabletting event. The derived force is then displayed and recorded in digital form.
摘要:
There is disclosed a method and apparatus for developing and controlling pharmaceutical granulations from a tabletting characteristics standpoint, involving instrumenting a tablet press to derive both the peak compression force and peak ejection force information for each tabletting event in convenient digital form. The thusly derived compression and ejection force information is automatically scaled to desired units of force and utilized in compression and ejection profiles and in the calculation of the average and standard deviations for both compression and ejection in the pursuit of optimization of the tabletted granulation regarding such tabletting characteristics as compressibility, lubricity, relative flow, compression failure point, and tendency of the formed tablets to adhere to the tablet press punches. In addition to the capability of distinguishing between the large-magnitude compression peaks and the relatively very small-magnitude ejection force peaks in the raw analog signal generated from a force transducer mounted on the tablet press, there is provided the capability of measuring ejection force peaks relative to a plurality of selectable reference levels, which enables the granulation formulator to take into account the residual force aspects found to exist following compression and prior to ejection of a formed tablet.
摘要:
There is disclosed instrumentation for use in connection with one or more tablet presses of various types, and in particular rotary tablet presses, for virtually any reasonable combination and number of such tablet presses. Tablet formation information, in particular compression and ejection force information, tablet capping information and information related to punch withdrawal is provided and processed by such instrumentation. This information is selectively applied to converting means which renders the selected information in a convenient data form for processing. Selection of the information may be made for example based on the need or desire to monitor a particular tablet press, tablet press station and/or individual tablet die/punch set combination. The selected information is processed by data processing means to provide output signals, including tablet press control signals, relating for example to the average and standard deviation of a pre-established number of consecutive tabletting events and determination of the frequency and number of abnormal tablet formations. The instrumentation may be employed to determine tabletting characteristics of pharmaceutical tablet granulations. Provision is also made for determining and isolating tablets failing to meet pre-established criteria.