Tablet dosage forms

VALIDATED HPTLC DETERMINATION AND CONTENT UNIFORMITY TEST FOR ALPRAZOLAM AND MELATONINE IN TABLET DOSAGE FORM... 

Bourquin J, Schmidli H, van Hoogevest P, Leuenberger H. Pitfalls of artificial neural networks (ANN) modelling technique for data sets containing outlier measurements using a study of mixture properties of a direct compressed tablet dosage form. Eur J Pharm Sci 1998 7 17-28. 

The effect of particle size reduction on the bioavailability of nitrofurantoin was shown in Fig. 4. The microcrystalline form (< 10 pm) is more rapidly and completely absorbed from the tablet dosage form than is the macrocrystalline form (74-177 pm) from the capsule dosage form. This is not a completely satisfactory illustration of the effect of particle size on the rate and extent of availability, since other manufacturing variables have not been held constant. Nevertheless, it does suggest some correlation between particle size, dissolution rate, and rate of availability. 

In the past, only tablet dosage forms of enzymatic cleaners were available. They required soaking lenses in solutions prepared from a tablet for a period of 15 minutes to more than 2 hours before disinfecting the lenses. Although this process provided sufficient time for cleaning, it was a cumbersome process and required multiple steps. Complicated or cumbersome processes... 

July 2002, Wyeth Pharmaceutical discontinued manufacturing cefixime, at the time of publication, Lupin, Ltd, which has FDA approval to market cefixime, had marketed only a suspension formulation of the drug and not the 400-mg tablet dosage form. Another recommended IM or po cephalosporin also can be used. 

After the administration of a syrup and tablet dosage form of a drug, the following data was obtained. What is the AUC of the liquid relative to the solid dosage form ... 

The average blood concentration of a macrolide antibiotic observed in a panel of twelve adult males following oral administration of 250 mg of the antibiotic in a tablet dosage form are given below ... 

Shafaati, A., and Clark, B. J. (1996). Development and validation of a capillary zone electrophoretic method for the determination of atenolol in presence of its related substances in bulk and tablet dosage form./. Pharm. Biomed. Anal. 14(11), 1547 — 1554. 

Polyelectrolytes (most notably ionic cellulose derivatives and crosslinked polyacid powders) are also commonly used as matrices, binders and excipients in oral controlled release compositions. In these applications, the polyelectrolytes provide hydrophilicity and pH sensitivity to tablet dosage forms. Acidic polyelectrolytes dissociate and swell (or dissolve) at high pH values whereas basic polyelectrolytes (for instance, polyamines) become protonated and swell at low pH. In either case, swelling results in increased permeability [290], thereby allowing an incorporated drug to be released. 

E. M. Rudnic and M. K. Kottke. Tablet dosage forms. Chapter 10 In Banker and Rhodes, eds. Modern Pharmaceutics. 3rd ed. Marcel Dekker, New York, 1995, pp 333-394. 

Use of these semisolid and solid approaches can potentially alleviate the chemical stability problems sometimes observed for liquid-Llled formulations, and may eventually offer the possibility of development of a tablet dosage form using conventional equipment. Liquid lipid-based formulations, however, generally afford the greatest enhancement of bioavailability for water-insoluble drugs, as well as affording more rapid development for First-in-Human studies. Any decisions on the best formulation route would have to be evaluated on a case-by-case basis. 

Nazzal, S., Nutan, M., Palamakula, A., Shah, R., Zaghloul, A.A., and Khan, M.A. (2002) Optimization of a self-nanoemulsi ed tablet dosage form of Ubiquinone using response surface methodology effect of formulation ingredientslnt. J. Pharm., 240 103-114. 

A program has been presented that can provide insight into the physical characteristics of a salt before the choice of a candidate for a tablet dosage form for oral administration, when the supply ofthe substance may still be limited to only 10-15 g (Graffneretal., 1985). Particle size, particle shape, the... 

Figures 23.3 through 23.5 illustrate the stepwise process low typically utilized in wet and dry granulation techniques for the manufacture of tablet dosage forms. For capsules, the process tends to be simpler with utilization of Lrst three steps from dry granulation followed by encapsulation in appropriate-size capsule shells. Depending on the batch size, a manual LHer (e.g., Bonapace), semiautomatic encapsulator (e.g., Capsugel Ultra 8), or automated encapsulator (Zanasi, Macofar, etc.) could be utilized for manufacturing.

A simple flow chart should be provided to show the logistical sequence of unit operations during product/process manufacture. A typical flow chart used in the manufacture of a tablet dosage form by the wet granulation method is presented in Figure 2. 

Figure 2 Process flow diagram for the manufacture of a tablet dosage form by wet granulation method. The arrows show the transfer of material into and out of each of the various unit operations. The information in parentheses indicates additions of material to specific unit operations. A list of useful pharmaceutical unit operations is presented in Table 6.

Figure 14 illustrates the construction of a table containing the results of end-product testing of 22 batches of a tablet dosage form. For simplicity, the product will be referred to as drug F. There are 22 rows and 14 columns, for a total of 308 data points. Each column has an abbreviated heading that describes the information contained therein. The headings are not needed for computer... 

Hygroscopicity. Special environmental working conditions may be required to ensure that moisture is not picked up during material storage or handling and during the manufacture of the tablet dosage form. 

Compression is a critical step in the production of a tablet dosage form. The materials being compressed will need to have adequate flow and compression properties. The material should readily flow from the hopper onto the feed frame and into the dies. Inadequate flow can result in rat holing in the hopper and/ or segregation of the blend in the hopper/feed frame. This can cause tablet weight and content uniformity problems. As for the compressibility properties of the formulation, it should be examined on an instrumented tablet press. Factors to consider during compression are as follows ... 

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... 

The following items should be considered when evaluating equipment for the manufacture of the tablet dosage forms. 

Many of properties and processes for hard gelatin capsules [19,48] are the same as with tablet dosage forms. Instead of covering these items again, only items that are unique to hard gelatin capsules will be discussed in this section. 

Encapsulation is a critical step in the production of capsules, similar to the compression step for tablet dosage forms. The materials to be encapsulated will need to have good flow properties and a consistent density. The materials may also need to be compressible in order to be dosed into the capsules however, they should also be easily deaggregated so not to adversely affect the dissolution of the drug. 

Bates,T.R.,andJ.A. Sequeria. 1975. Bioavailability ofmicronized griseofulvin from corn oil-in-water emulsion, aqueous suspension, and commercial tablet dosage forms in humans. J Pharm Sci 64 793. 

Lachman L. Physical and chemical stability testing of tablet dosage forms. J Pharm Sci 1965 54 1519-1526. 

D.A. Shah, K.K. Bhatt, R.S. Mehta, M.B. Shankar, S.L. Baldania, RP-HPLC method for the determination of atorvastatin calcium and nicotinic acid in combined tablet dosage form, Indian J. Pharm. Sd. 69 (2007) 700-703. 

N. Jain, R. Raghuwanshi, D. Jain, Development and validation of RP-HPLC method for simultaneous estimation of atorvastatin calcium and fenofibrate in tablet dosage forms, Indian J. Pharm. Sd. 70 (2008) 263-265. 

Quantitative and/or qualitative XRPD methods have been reported to determine the polymorphic content of clopidogrel bisulfate samples, and these have been summarized in Table 2.3. Koradia et al. [16] reported the qualitative analysis of clopidogrel bisulfate in both active pharmaceutical ingredients and tablet dosage forms. Based on the interplanar distances (d-spacing) associated with each polymorph, it was concluded that the molecular packing in Form-I was more dense than that of Form-II, indicating that Form-II would be less stable relative to Form-I. This result was similar with that reported by Bousquet [9]. 

Kamble and Venkatachalam [23] reported a gas chromatography (GC) method for the determination of clopidogrel in tablet dosage forms. This method used a DB-17 capillary column of 30 m length and 0.25 mm internal diameter, equilibrated at an oven temperature of maintained at 250 °C. Dioctyl phthalate was used as an internal standard, and clopidogrel was detected at 4.1 min by means of a flame ionization detector. Linearity in the method ranged from 0.5 to 5.0 mg/ml, with a recovery of 99.89%. 

Roos, R.W., Determination of conjugated and esterified estrogens in pharmaceutical tablet dosage forms by high-pressure, normal-phase partition chromatography, J. Chromatogr. Sci., 14, 505, 1976. 

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