Tablet production methods

Gradient HPLC Yes/No Complex Low Receiving site has extensive familiarity with other products and methodologies of this compound, but not with this dosage form, e.g. tablet product/method is established, but no experience of this oral liquid product. Method has a good history of reproducible performance. Method confirmation... 

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. 

Otilonium bromide Powder and tablet Non-destructive quantitation method for QC of three production steps (blend, cores and coated tablets). Validated method following ICH guidelines. Relative errors lower than 1 % 147... 

Ibrahim, Y. . E., and Olurinola, P. R. (1991), Comparitive microbiological contamination levels in wet granulation and direct compression methods of tablet production, Pharm. Acta Flelv., 66, 298. 

General information Product, including description (e.g., tablet, dose) method name, including revision and technique (e.g., UV) project information concerning sample(s) date of test and lot number equipment identifier raw data file name of computerized system and analyst. 

When the lubricant should not be part of the tablet formulation, for example, when bonding properties of the drug are low, external lubrication is necessary [197], For single-tablet production the punches and dies can be manually lubricated with a fluid. In production several methods have been developed to place the fluid on the surface of punches and dies [198], Filaments applied at the punches to lubricate the die or special caps with fluid lubricant are possible solutions. However, external lubrication also has disadvantages [199],... 

Basket Apparatus. This method is very similar to the one described above except that the inverted T-shape stirrer is replaced with a cylindrical metallic-wire basket (Fig. 4). The tablet product is placed in the basket that is attached to the spindle, which provides rotation to the basket. The dissolved drug comes out of the basket and mixes with the bulk medium. In this apparatus, it is possible that when the product is disintegrated and particles drop and settle at the bottom of the vessel without dissolving thus providing limited dissolution. Therefore, one may anticipate erratic dissolution results using such an apparatus, at least for some products. 

Lubrication of the die and punches is essential for many solid dosage formulations to prevent material sticking to the equipment surfaces during tablet production. The amount of lubrication, technique to apply the lubrication, and method of addition can have large effects on the die wall friction during the compaction process. Various techniques exist for lubrication of the compaction simulator dies. The most prominent method for manual die lubrication is to brush the die with a magnesium stearate suspension (e.g., in methanol). This technique is easily controlled however, it can be time intensive and may not be... 

Most pharmacopoeias specify that ethambutol hydrochloride contains not less than 98.0% and not more than 100.5% of C10H24N2O2 2HCI, calculated on the dried basis. Pharmaceutical products such as tablets must contain not less than 95.0% and not more than 105.0% of the labeled amount.As for pyrazinamide, the main pharmacopoeia assay method for ethambutol is a titration method. However, an HPLC method is used for the assay of ethambutol HCl in tablets.This method requires that a liquid chromatograph equipped with a 200-nm detector and a 4.6 mm X 15 cm base-deactivated column that contains 5 p,m porous silica particles, 3-10 p,m in diameter, with chemically bonded nitrile groups (CN, LIO) is used. The mobile phase is a mixture of 1.0 ml of triethylamine and 1 L of water, adjusted with phosphoric acid to a pH of 7.0. The flow rate is about 1.0 ml/min. Separately inject equal volumes (about 50 p.1) of standard preparations and the assay preparations into the chromatograph, record the chromatograms, and measure the responses for the major peaks and calculate the quantity, in mg, of ethambutol hydrochloride present in the tablets from the peak responses obtained from the assay preparation and the standard preparation, respectively. The tailing factor must not be more than 2.0, and the relative standard deviation for replicate injections not more than 2.0%. 

All the previous sections provided an overview of all the possible technologies to manufacture effervescent granules but how to choose the most appropriate technique for a certain formulation. An interesting study to figure out the best production method for effervescent tablets was presented by Laugier and Rona (Table 2) (37). 

The in-use performance and handling of agglomerated or tabletted products is often closely related to structure (e.g., porosity) and mechanical properties (hardness, yield stress, modulus, toughness, etc.). The compaction diagram is a useful method to measure the properties of granular materials as well as the characterization of bulk structures (e.g., tablets) formed by compaction. 

Properties of lakes that enhance their usefiilness iaclude their opacity, their abiUty to be iacorporated iato products ia the dry state, their relative iasolubihty, and their superior stabiUty toward heat and light. Such properties have made possible the more effective and more efficient preparation of candy and tablet coatings, and often eliminate the need to remove moisture from dry products before coloring them. Lakes have also made possible the coloring of certain products that, because of their nature, method of preparation, or method of storage, caimot be colored with ordinary color additives. 

Estimation of Other Alkaloids in Opium. Of the other alkaloids the most important is codeine, and processes for its estimation in opium have been described by Cespari, Andrews,and Annett and co-workers methods for its assay in admixture with other drugs in tablets and other products are also available. The estimation of papaverine has been described by Issekutz,i and of narcotine by Snesarov. As to methods for the separation and estimation of two or more of these subsidiary alkaloids, codeine and narcotine have been dealt with by van der Widen,narcotine and papaverine by Annett and Bose, ( and the bromination of codeine and narceine has been studied by Vaisberg et al. with a view to estimation by this means. 

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