Tablet tolerance limits

Tablet weight Action limit N — IQ (%) Tolerance limit N — IQ (%)...

Average first-layer tablet weight (n — 20) Individual first-layer tablet weight (n = 20) Average bilayer-tablet weight (n — 20) Individual bilayer-tablet weight (n — 20) Eirst layer-tablet cylindrical height Action limit 1.1% Tolerance limit 1.7% Action limit 2.0% Tolerance limit 3.0% Action limit 1.1% Tolerance limit 1.7% Action limit 2.0% Tolerance limit 3.0% 2.45-3.00 mm... 

PYAP Tablet coatings/ink component for capsules Single dose in various species, repeat dose (oral gavage or diet and up to 2 yrs in duration in rat and dog) and reproduction (fertility study in rat, embryo-fetal studies in rat and rabbit, and peri-postnatal study in rat) toxicity Well tolerated [limited extreme high-dose effects seen (Table 3)]... 

Modern systems combine one of these control systems with automatic weighing of tablets. Weight control will automatically adjust the filling depth in order to keep tablet weight within specified tolerance limits. 

Table 1 Tablet weight-control points and tolerance limits...

UTLw, Upper tolerance limit of individual tablet weight 105.0... 

UTL Upper tolerance limit of average tablet weight 103.0... 

If during any check the average tablet weight exceeds the average tolerance limits (below 97 mg and above 103 mg) or an individual tablet exceeds the individual tolerance limits (below 95 mg and above 105 mg), the machine will shut off and reject the tablets. It is important to note that individual tablet weights exceeding the tolerance limits indicate that the tablet rejection system is not functioning properly. 

When the average tablet hardness is plotted against the average compression peak force, we get the so-called compactibility profile that allows us to compare different formulations or different processing speeds. Referring to Fig. 8, which formulation is better Well, formulation No. 2 makes harder tablets for the same compression force, and this would mean less wear and tear on the production press is required to achieve desired hardness. On the other hand, if the hardness tolerance limits are exceptionally narrow, the steeper slope of formulation No. 2 may be a detriment. 

To keep tablet weight within the prescribed tolerance limits, the required instrumentation includes compression... 

Systemic Effects. Although acetazolamide is effective as an ocular hypotensive agent, a significant number of side effects limit its clinical usefulness (Box 10-5). Maximal doses of CAIs produce intolerable effects in 30% to 80% of patients. The incidence of side effects varies with the dose and the fitrmulation however, when all side effects are considered, the incidence probably approaches 100% in patients taking either acetazolamide tablets or the 500-mg sustained-release capsules. One study demonstrated that only 26% of patients could tolerate acetazolamide tablets beyond 6 weeks, whereas 58% of patients could tolerate prolonged use of the sustained-release formulation. 

During normal production with the force control system in operation as specified above, the tablet press will operate to maintain the constant compression force of 10 kN by adjusting the fill depth (Fig. 9). Most force control systems do not require the user to input the upper and lower force control limits for average compression force that are typically set by the manufacturer within tighter tolerances than those demanded by the weight requirements. The control system typically calculates the average compression force every revolution and compares it to the force set point. If the average measured compression force varies from... 

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