Tablet manufacture

The various preparation processes and technologies used in dmg product manufacture also can effect product safety, stabihty, and performance, eg, compression during tablet manufacture. The principal processes used in dosage form manufacture are as foUows (15). 

Situation During the introduction of a new tablet manufacturing process, the operation of a conditioner had to be validated the function of this conditioner is to bring the loaded tablets to a certain moisture content for further processing. 

ITMs provide a valuable service to all phases of tablet manufacture, from research to production and quality control [109 111]. As a research tool, ITMs allow in-depth study of the mechanism of tablet compaction by measuring the forces that develop during formation, ejection, and detachment of tablets. ITMs can also provide clues about how materials bond,... 

Tiltabs. Tiltab tablets represent one of the few dosage formulations that has been developed expressly to meet the needs of patients with impaired dexterity [185], Marketed by Smith, Kline French Laboratories, Ltd. in several European countries, the novelty of the Tiltab design is its irregular shape that prevents it from lying flat. Apparently, tablets manufactured in this fashion are easier to handle by those with impaired dexterity. Moreover, these tablets are readily identifiable by patients so that differentiation from other medication is facilitated. Other innovations like this are needed for drug-delivery systems with the particular needs of the geriatric patient in mind. 

SS Kornblum, JO Hirschorn. Dissolution of poorly water-soluble drugs I. Some physical parameters related to method of micronization and tablet manufacture of a quinazolinone compound. J Pharm Sci 59 606-609, 1970. 

Patel et al. [40] found that moismre and the pH of the micro-environment influenced degradation the most. They identified the best diluent for tablet manufacture as being dibasic calcium phosphate, with a basic modifier (sodium carbonate, sodium bicarbonate or magnesium oxide). The authors indicated that the degradation pathways observed were deiodination, deamination and decarboxylation. The data are shown in Table 2.4. 

The tablet was introduced by Thomas Brockedon in 1843, and glyceryl trinitrate tablets appeared in the British Pharmacopoeia of 1885. Since that time, many variations have appeared but the basic process remains unchanged. There are three main methods of tablet manufacture, with choice depending on the dose and the drug s physical properties such as compressibility and flow (Figure 2.2). A drug with a large... 

Tablet hardness, friability, disintegration time and dissolution at 30minutes were the response variables that were measured. Tablets manufactured at 10 and 12kN were compared, as well as their compaction profiles. Table 4 shows the results from the fractional factorial DOE and Figure 19 shows the compaction profiles from the 20 batches.

Granulation particle size did not impact the release rate. In addition, tableting at various compression forces had no significant impact on the release rate of the tablets. This knowledge that variability in tablet manufacture resulted in a uniform sustained release dosage form provided an advantage for further process optimization and scale-up, as shown in Figure 23. 

Figure 5 Scans of commonly used excipients for tablet manufacture. Key-MCC (Avicel PH101),—MCC (Avicel Ph200), Lactose (Foremost 325),—dibasic calcium phosphate (di-tab) and—Mg Stearate.

Fig. 10.9. Raman monitoring of tablet content uniformity during tablet manufacturing...

Observation— The revalidation of the. .. tablet manufacturing process was inadequate in that only one batch was subjected to limited validation testing for a change in the order of charging raw materials and the addition of a screening process for the pre-blending step. This process change was initiated after two batches had failed blend uniformity specifications. ... 

TABLE 2.6 Typical Unit Operations, Process Parameters, and Quality Attributes for Tablet Manufacture... 

TABLE 5.4 Process Parameters and Uniformity Data for Tablets Manufactured Using Different Granulation Methods... 

Direct compression is a simpler alternative tablet manufacturing method. With direct compression, tablets are compressed directly from a powder mixture of an API and appropriate excipients. Like granulation methods, this approach is also based on the required flow, compressibility, and compactibility of a formulation. Direct compression offers both time and economic advantages by eliminating intermediate granulating and drying steps. 

Compared to wet granulation and roller compaction, the direct compression platform allows tablet manufacture with fewer unit operations, as listed in Table 7.1. The sections that follow discuss several advantages and disadvantages of using direct compression for tablet manufacture. 

TABLE 7.1 Comparative Unit Operations in Tablet Manufacture Using Wet Granulation, Roller Compaction, and Direct Compression... 

Microcrystalline cellulose - mainly used as a binder or diluent in solid oral dose formulations. It also has lubricant and disintegrant properties which make it a useful excipient in tablet manufacture. 

Special attention should be given to the physical stability of the tablets manufactured by direct compression because some fillers/binders are known to soften or harden on storage. 

Core benefits include the avoidance of tablet manufacturing problems such as punch tip breakage from the outset. Immediate and accurate punch tip load calculations and 3D dynamic rotation of punch tip stress allow for instant decision making on design issues. iTAB is also unique in that it incorporates tooling and tablet... 

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