The correct answer is: False. In tablet compaction, the initial step when the punch enters the die is plastic deformation, not elastic deformation. Elastic deformation refers to reversible changes in shape, whereas plastic deformation involves permanent changes in shape due to compression forces. Therefore, the statement is not accurate.
The correct answer is: "Overall swelling - a significant increase in volume". Sodium starch glyconate, as a disintegrant, undergoes significant swelling upon exposure to moisture, resulting in an overall increase in volume. This swelling causes the tablet to break apart, enhancing its dissolution rate. Therefore, the answer accurately describes the mechanism of action of sodium starch glyconate as a disintegrant.
Croscarmellose is a disintegrant that, upon exposure to moisture, undergoes radial swelling of its deformed fiber-shaped particles, causing them to straighten out. This expansion facilitates the breakup of the tablet into smaller particles, aiding in rapid dissolution. Therefore, the answer accurately describes the mechanism of action of Croscarmellose as a disintegrant.
The correct answer is "cannot predict without more information". While increasing the compression force can potentially impact the disintegration rate, the effect depends on various factors such as the specific formulation and characteristics of the material. Without additional details about the tablet composition and behavior, it's uncertain whether the rate at which the material breaks down would slow down or be affected differently. Therefore, the chosen answer correctly indicates that the outcome cannot be determined without more information.
The correct answer is: False. Direct compression is a tablet manufacturing method that eliminates the wet granulation process, thereby reducing the number of steps required for tablet production compared to other methods. Although it avoids exposing the drug to heat and moisture, it does contribute to a streamlined manufacturing process. Therefore, the statement's assertion that it doesn't reduce the number of steps is inaccurate.
The correct answer is: FALSE. The statement is not accurate. Microcrystalline cellulose is commonly used as a filler and binder in tablet formulations, even for drugs with poor compaction properties or low dose. It aids in improving compressibility, flowability, and binding characteristics, making it possible to create tablets of large doses and poorly compactable drugs through direct compression. Therefore, the assertion that microcrystalline cellulose can't be used for poorly compactable drugs or large doses is incorrect.
The correct answer is: TRUE. The statement accurately reflects that while direct compression avoids exposing a drug to heat and moisture, it doesn't significantly reduce the number of steps involved in tablet manufacturing compared to other methods like wet granulation. Therefore, the assertion that direct compression doesn't substantially decrease the steps required for tablet production is correct.
The correct answer is "Recovers shape with little or no increase in volume". Starch, as a disintegrant, maintains its original shape within a tablet while undergoing minimal volume increase upon exposure to moisture. Unlike other disintegrants that significantly swell or deform, starch helps the tablet fragments disintegrate by its ability to recover its shape without significant expansion. Therefore, the answer accurately describes the mechanism of action of starch as a disintegrant.
The correct answer is" increase". Reducing the lubricant blending time from 15 minutes to 2 minutes could lead to an increased dissolution rate of xy1000 from the tablets. A shorter blending time might result in less uniform distribution of the lubricant, potentially allowing for faster tablet disintegration and drug release. Therefore, the selected answer accurately indicates that the dissolution rate is likely to increase with this change.
The correct answer is " None of the above". Among the options provided, "Dipac" and "Ditab" are not typically recognized as common filler-binders in chewable tablets. Calcium carbonate, however, is a widely used filler and binder in chewable tablets due to its properties that enhance tablet characteristics. Therefore, the chosen answer is incorrect, as none of the provided options accurately represent a common filler-binder used in chewable tablets.
The correct answer is "50% intragranularly / 50% extragranularly". The most effective method to incorporate sodium starch glycolate is by adding it both intragranularly and extragranularly in equal proportions (50% each). This approach optimizes its disintegration properties during tablet dissolution, promoting efficient breakup and drug release. Therefore, the selected answer accurately reflects the recommended method for adding sodium starch glycolate.
The correct answer is "decrease". Replacing sodium starch glycolate with an equal amount of starch in the formulation is likely to result in a decreased dissolution rate of XY1000 from the tablets. Sodium starch glycolate is a disintegrant that aids in tablet breakup and dissolution, and substituting it with starch may lead to reduced disintegration efficiency and slower drug release. Therefore, the selected answer accurately suggests that the dissolution rate is expected to decrease with this substitution.
The correct answer is "Polysorbate 80". Among the options provided, "Polysorbate 80" is not suitable for carrying soft gelatin capsule fill materials. While cottonseed oil and polyethylene glycol 400 are commonly used as carriers in soft gelatin capsules, polysorbate 80 may not provide the required compatibility or stability for certain fill materials. Therefore, the selected answer accurately identifies Polysorbate 80 as the liquid that cannot be used to carry soft gelatin capsule fill materials.
The correct answer is "have a little effect on". Substituting magnesium stearate with an equal amount of calcium stearate might cause a minor impact on the dissolution rate of xy1000 from the tablets. While both stearates are lubricants, the small change in formulation is unlikely to significantly alter the dissolution properties. Therefore, the selected answer accurately reflects that the substitution would have a modest influence on the dissolution rate.
The correct answer is: FALSE. The statement is not accurate. True lubricants in tablet manufacturing do help in easing the tablet ejection process by reducing friction between the tablet and the die walls, but they don't specifically lower the force left in the die wall. Instead, they minimize adhesion between the tablet and die, aiding in smoother ejection. Therefore, the assertion that true lubricants reduce ejection force by lowering the force left in the die wall is incorrect.
The correct answer is: FALSE. The statement is not accurate. While it's true that the compressive force applied during tablet manufacturing affects tablet characteristics, the amount of force is not directly related to how hard the tablet is or how easily it breaks. Factors like formulation, excipients, and compression speed also influence tablet hardness and friability. Therefore, the statement's assertion is false.