Quality pharmaceutical tablet

Satisfaction is not to be confused with dimensions of quality such as 1) quality of conformance or 2) quality of design. Quality of conformance is the consistency of how the product is manufactured or the service is delivered. For example, pharmaceutical tablets are manufactured to fit within FDA standards for dissolution. Each batch is tested to determine if tablets within that batch fit standards. Quality of design is how well the product or service meets the needs of consumers or how well the product or service compares with those of competitors in the eyes of the consumer. In the pharmaceutical tablet example, the manufacturer would evaluate the quality of design by comparing the clinical outcomes provided by the product to the desired outcomes of the patients. Such factors as returning to normal health or avoiding side effects would be used in the evaluation of quality of... 

There is a general belief that pressure must always be applied to a sample in order to obtain its FT-IR image in the ATR mode. Whilst it is important to ensure homogeneous contact between the sample and the ATR crystal, such that the image would not represent only the quality of the contact, there is often no need to apply pressure in this situation. Examples in macro ATR imaging include the swelling pharmaceutical tablets or biomedical tissues, whereby a good and repro-... 

The simplicity and robustness of the method makes it well suited to a number of practical analytical applications, such as sensitive noninvasive in vivo disease diagnosis, security screening and the quality control of pharmaceutical tablets. The concept is also potentially applicable to fluorescence spectroscopy, NIR tomography of turbid media and other general applications, where the enhanced coupling of laser radiation into a turbid medium is beneficial an example is the case of photodynamic therapy in cancer treatment of subsurface tissues. 

The process/quality control strategy for the manufacture of detergent tablets is largely based on the approach developed for pharmaceutical tablets. The tablet weight is controlled by the fill cam position. In modem presses, this will be a motorized adjustment and is linked by a feedback control loop based on the compression force. Typically, this can achieve a weight variation of less than +/ 4% (three relative standard deviations), since for a given material the compression force is... 

Probing of Pharmaceutical Tablets and Capsules in Quality Control... 

R.C. Lyon, D.S. Lester, E.N. Lewis, E. Lee, L.X. Yu, E.H. Jefferson and A. S., Hussain, Near-infrared spectral imaging for quality assurance of pharmaceutical products analysis of tablets to assess powder blend homogeneity, AAPS Pharm. Sci. Tech., 3(3), 1-15 (2002). 

Tablets account for more than 80% of all pharmaceutical formulations therefore, the development and implementation of NIR methods for determining APIs in intact tablets is of a high interest with a view to assuring content uniformity and quality in the end product. Blanco et al developed an innovative strategy to prepare calibration samples for NIR analysis by using laboratory-made samples obtained by mixing the API and excipients in appropriate proportions and compacting the mixture at a pressure similar to that used industrially. This way of matching laboratory and production samples affords more simple and robust NIR methods which require the use of neither HPLC nor UV-vis spectroscopy as reference rather, reference values are obtained by weighing during preparation of the samples. The PLS calibration models thus constructed exhibited a good predictive ability with various production batches.

In addition to these regulatory issues there are some homemade limitations to common quality documentation (e.g. normally, pharmaceutical companies prefer to market tablets in polyethylene bottles in the United States, in contrast to blister packs for the European market and different trade names, colours or pack sizes are also unavoidable in certain cases). The consequence of these differences is the fact that a common Module 3 (Quality) and therefore a common Quality Summary in Module 2 cannot be compiled. 

Example 2 In a Pet Tabs (pet vitamin tablets) production, the pharmaceutical manufacturer is using milling and micronizing machines to pulverize raw materials into fine particles. These finished particles are combined and processed further in mixing machines. The mixed ingredients are then pressed into tablets, dried, and sealed in packages. A normally distributed quality characteristic, moisture content, is monitored. Samples of n = 4 tablets are taken from the manufacturing process every hour. The data after 25 samples have been collected are shown in Table 5. 

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