Tablet products

CU-ASSAYLdat (Fig. 4.40) A tablet production process was being validated samples were pulled from the beginning, the middle, and the end of the production run Components A and B were analyzed. The requirement is that the means do not significantly differ and that the CV remains below 6%. 

The effect of raw material variability on tablet production [2,30,31] and suggestions for improving tableting quality of starting materials [21] has been the subject of several publications. Table 3, which lists the characteristics of different sources of magnesium stearate, clearly illustrates the variability of this material [32]. Phadke and Eichorst have also confirmed that significant differences can exist between different sources, and even different lots, of magnesium stearate... 

Class I recalls are those that have been judged to present a serious threat to the health of the consumer. Examples of this type of recall include brewers yeast tablets (product contaminated with Salmonella), defective pacemakers (electronically unsafe), and numerous cases of mislabeling of drug substances, such as the belladonna alkaloids [20]. 

Tablet. Production yields from coal carbonization...

This equipment has one calibrator tablet a single tablet product, chlorpheniramine extended-release tablets (drug-release calibrator, single unit). It has been found that this equipment is not particularly sensitive to vibration and has reliable and consistent operation (17). 

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... 

S.M. Han and P.G. Faulkner, Determination of SB 216469-S during tablet production using near-infrared reflectance spectroscopy, J. Pharm. Biomed. Anal., 14, 1681-1689 (1996). 

Fig. 2.2 The tablet production process. Process stages are shown in boxes.

In this example, a high dose ( 75% drug loading) wet granulated tablet product was transferred between development sites. The following issues were noted after transfer of the product ... 

The Tandem system (Bruker Optics) is available for use during tablet production to measure tablet weight, thickness, hardness, and diameter, as well as online NIR content uniformity. The system can provide online analysis for drug substance uniformity, moisture content, and excipients. The advantage of systems like this is that the necessary data are available immediately to make adjustments to the production parameters in order to improve product rmiformity. Therefore, adjustments can be made to tablet weight in real time in order to achieve 100% of the label claim. 

This case study will summarize the development of a pan-coating process designed for the application of an enteric coating to a tablet product, provide insight into some of the early process optimization studies that were undertaken, and show how these ultimately facilitated the development of production-scale manufacturing processes. 

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. 

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. 

Connolly, R. J., Berstler, F. A., and Coffin-Beach, D. (1990), Tablet production, in Pharmaceutical Dosage Forms, Tablets, Marcel Dekker Inc, New York. 

Future work will be necessary to complete EMPA analysis for all of the curse tablets. It may be possible to refine the current classification system of least to most inclusions to include considerations of which elements and/or alloys are present in the tablets. A protocol will then be written and used to choose 24 additional samples for TIMS analysis. The goal is to clarify the sources of lead used for curse tablet production. In conclusion, future work in the expansion of the limited Tunisian lead ore database will focus on resolving the current problem regarding the overlap of important ore sources. 

This is usually a transition stage between the laboratory and the projected final process. Figure 4 also shows typical responses that may have to be evaluated during the ranging studies on the tableted product. 

The medical dosage of the contaminated product—The typical (some companies use maximum) daily dosage of a potentially contaminated product should be considered in the determination of limits. The idea here is simply that whatever the level of cross-contamination, the more of the contaminated product the patient consumes the greater the amount of contamination taken by the patient. Consider a tableted product. If the daily dose of the tablet is 24 tablets per day, the patient will receive 24 times as much contaminant than if the daily dose of the product was one tablet per day. 

Third, after the tablet is compressed, the upper punch is withdrawn from the die and lower punch moves upwards to eject the tablet. Successful ejection of tablets without chipping or sticking requires sufficient lubrication of the powder blend so there is minimum adhesion between the tablet and the die wall. Lower ejection forces are preferred during tablet production to avoid unnecessary mechanical wear on the tablet press. 

NDA process. A medical review of the data led to the conclusion that in the 12-hr time frame between API HC1 administrations the 25-min difference in reaching the specified 85% dissolved material was of little consequence. It was also observed that by the use of a higher pressure in tablet production, a tablet dissolution rate conforming to tablets of marketed product could be created. 

The manufacture of a processed Helianthus tuberosus product, characterized by the addition of natural oily vitamin E, is described. This provides a tableted product that can be easily prepared in desired amounts by diabetics. The tablets are preferably obtained by slicing, drying, and pulverizing H. tuberosus tubers and adding citric acid to the powder, and then the natural vitamin E in an amount of about 0.03 wt%. 

Postprocessing and product sections (e.g., tableting, product drying, etc.)... 

Vaginal tablets containing lactobacilli have been used in order to restore the normal vaginal flora. Formulation of these delivery systems requires specific proceedings in order to provide viability of lactobacilli and stability of the final product. Freeze drying of bacterial suspensions has been tested to obtain lyophilized powders for tablet production [81]. These powders were shown to be processable and tablet production was easy and reproducible. Also, the use of double-layer tablets (fast-release layer and slow-release layer) seems to be an interesting approach to lactobacilli administration. 

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