Manufacturing tablets

The Bioavailability Monograph for Erythromycin27 provides data for comparison of several manufacturers tablets of erythromycin. The criteria for bioavailability tests are discussed. 

Finally, knowledge of excipient mechanical and physical properties is essential to creating a robust formulation that manufactures tablets that meet specifications in a time- and material-efficient manner. Excipient selection must also take into consideration API stability and biopharmaceutical performance of the dosage form. Uneducated selection of excipients will likely lead to numerous formulating iterations that require much time and material, which are luxuries that product development scientists do not have in the competitive pharmaceutical environment. 

In an ideal situation, the equipment used to manufacture tablet dosage forms would be selected based on such factors as formulation, safety requirements, handling/production efficiencies, and commercial demands. In reality, the equipment used is usually what is already available at the development facility or production plant. In either case, the equipment should be qualified (installation and operation) before being used. Cleaning procedures should also be available... 

Chitin was evaluated as a direct-compression vehicle using powder flow properties and the physicomechanical properties of the manufactured tablets, and it was proven that this natural polymer has suitable characteristics for being used for this end. 

Tablets remain one of the most popular dosage forms for consumers. Convenience, portability, and ease of administration are a few of the factors that drive the market for tablets. Pharmaceutical production also favors tablets owing to the low cost of manufacture compared to other dosage forms. To reduce associated costs and balance the limited drug substance available, tablet development usually begins at a small scale. Manual equipment (i.e., Carver press) or a singlestation tablet machine (i.e., F-Press, EKO) may be used to manufacture tablets one at a time. Small-scale rotary tablet presses (e.g., B3B, BetaPress) are usually used for early clinical trials and formulation optimization prior to scaling up onto a production machine (e.g., Fette 2090 or 3090).

The methods of formulating and manufacturing tablets have been described in the preceding sections. Each method has certain unique benefits and advantages as well as drawbacks, and these are summarised in Table 11.14. 

Once manufactured, tablets will be controlled for weight and weight variation, appearance, disintegration active... 

Polymorphism is a characteristic of the solid state and the concept is immensely important in the pharmaceutical industry. Properties such as stability, solubility, bioavailability, manufacturability, tableting, formulation, and even toxicity are a function of the polymorph crystal structure. 

The main criticisms of locally manufactured medicines raised by private sector respondents in both countries concerned packaging, which was said to compare poorly with imported competing items, putting off users. In Tanzania, there was repeated criticism that some locally manufactured tablets tended to disintegrate too easily, and some unfavourable comparisons with the quality of Kenyan manufactured tablets. 

Wet granulation and direct compression are two methods used to manufacture tablets in the pharmaceutical industry. Zomer et al. used pyrolysis-gas chromatography-mass-spectrometry coupled with SVM classification to discriminate between the two tablet production methods.Mass spectra data were submitted to a PCA analysis, and the first principal components were used as input for SVM models having linear, polynomial, and Gaussian RBF kernels. SVM classifiers with polynomial and RBF kernels performed better in prediction than discriminant analysis. 

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