What is the difference between scored and unscored tablets

The tablet dimensions, hardness, disintegration and content uniformity must meet the critical quality attributes as registered by the manufacturer. Operation of the tablet press is no different for a tablet with a score and one that is not scored. While there is guidance with respect to assessing the quality attributes of tablets that have been split, there is currently only recommended testing of the tablets that result from the splitting of the original tablet.

PTE:To ensure that tablets can be split evenly with good dosage content uniformity, what factors do tablet manufacturers need to take into account?

Kettler: Design of the tablet and ultimately the performance of the dosage form to deliver the availability of the API will dictate the tablet shape and configuration of the score. Considerations for the targeted patient population need to be taken into account; for example, the ability of the targeted patient population to split a tablet should be factored into the design of the scored tablet.

Elderly patients or those with limited strength in their hands will require a tablet that is readily split, perhaps at the expense of overall tablet strength.

Moreover, the relative standard deviation was between 1. Warfarin 5 mg subdivided tablets failed the weight variation test regardless of the subdivision technique used. Subdivision by knife produced half tablets that were acceptable only for candesartan tablets. However, the tablet cutter produced half tablets that passed the weight variation test for four out of the five drug products tested in this study. The tablet cutter performed better than the other subdivision techniques used.

It produced half tablets that passed the weight uniformity test for four drug products out of the five. Tablet subdivision can be used by patients for a variety of reasons. However, subdividing tablets might not be a recommended practice.

Tablets for controlled release purposes and orally disintegrating tablets might lose predesigned properties when subdivided. However, in real life practice, there is a variation in the degree of accuracy in obtaining equal halves. However, combination of the binder hydroxypropylcellulose with microcrystalline cellulose in the formulation improved the subdivision accuracy of the tablets.

Several studies have investigated the accuracy of different tablet subdivision techniques. Researchers compared the results of subdividing paracetamol mg tablets which were round, flat, and uncoated obtained by tablet splitter cutter , kitchen knife, and hand. They found that the accuracy of tablet subdivision was best achieved by hand. In the tablet subdivision practices in Jordan as well as the frequency of using different techniques for tablet subdivision were investigated.

Tablets of five commonly subdivided medications in Jordan were used in this study. Tablet dimensions were determined using a Vernier caliper. The thickness and diameter of ten tablets of each drug product were measured.

The thickness of bi-convex tablets was measured in the center and on the side of the tablet. The difference was used as an indication of the extent of face curvature. In addition, the thickness was measured from inside the score-line s if present on the tablet and used as an indication of score depth. Ten tablets of each drug were analyzed. A year-old right-handed female pharmacist volunteered to carry out all tablets subdivisions.

Ten tablets of each drug product were subdivided by each of the studied subdivision techniques: by hand, by kitchen knife, and by a tablet cutter. The weight of each tablet and the resulting subdivisions were measured using a digital balance Phoenix Instument-ASN, Garbsen, Germany. All subdivisions were performed along the score-line if present. Subdivision by a kitchen knife was performed by placing the tablet on the bench top, placing the sharp side of the blade along the score-line, if present, and then pressing on the non-sharp end of the blade in one hand while holding the handle in the other hand.

The kitchen knife blade was made of stainless steel with a length of 7. The handle of the knife was made of plastic with a length of The tablet cutter used in this study was a non-brand plastic splitter commonly available in the market in Jordan.

The dimensions of the tablet cutter box were 7. The metal blade of the cutter had a thickness of 0. The tablets were placed at the closest point towards the hinge of the cutter inside the designated area on the base plate of the cutter which was parallel to the horizontal plane along the x-axis.

This designated area resembled an oval in shape with axis of symmetry major axis along the direction of the cutting blade with a length of 3.

The wider region of the oval shaped area laid closer towards the hinge of the cutter. The maximum width of the oval region was 2. This designated area had a wall ridge of a height of 4. This opening in the wall had a width of 4. The distance between the hinge and the wall opening is equal to 1. With this geometry, it is expected that the radii of tablets tested in this study had little effect on the distance between the hinge of the tablet cutter and the point at which the cutting blade starts acting on the placed tablets.

Somogyi et al. Purpose: This U. Food and Drug Administration FDA laboratory study examines the impact of tablet splitting, the effect of tablet splitters, and the presence of a tablet score on the dose uniformity of two model drugs. Methods: Whole tablets were purchased from five manufacturers for amlodipine and six for gabapentin. Two splitters were used for each drug product, and the gabapentin tablets were also split by hand.

The USP weight variation method was used for gabapentin split tablets based on the recommendation of the guidance. Variation in whole tablet content ranged from 0. Whole and split amlodipine tablets were tested for content uniformity following the general chapter of the United… Expand. View on PubMed.

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