It’s fairly common practice to split tablets along the functional scoreline either to adjust the dose or as a cost saving measure. However, in some instances, there is a risk of tablets breaking in uneven parts causing loss of product thus impeding the dosing accuracy. The split tablet portions may also have stability issues.
To address these concerns and ensure consistent scoring and dosing accuracy for tablets split along the functional scoreline, the United States Pharmacopoeia (USP), the European Pharmacopoeia (EP) and CDER Guidance on Tablet scoring (March 2013) have established a list of tests and acceptance criteria.
This post summarizes the typical tests and acceptance criteria by which scored tablets can be evaluated and labeled.
As per USP General Chapter <705>,
1. Take a random sample of 30 intact tablets, and proceed as follows.
2. Accurately weigh each tablet, and record its weight.
3. For each intact tablet, determine the expected weight of the split portions by dividing the whole-tablet weight by the designated number of split portions indicated on the labeling.
4. Split each tablet by hand (without mechanical assistance) into the designed number of split portions, and weigh each split portion.
5. For each tablet, determine the percent of the expected weight in each split portion.
An acceptable tablet breaks into the designed number of segments, and each split portion has NLT 75% and NMT 125% of the expected weight of the split tablet portion. [ NOTE— Set aside split tablet portions derived from acceptable tablets for subsequent testing for dissolution or disintegration.]
Acceptance Criteria: NLT 28 of the 30 tablets are acceptable.
Dissolution
Use split portions from tablets that are acceptable according to the Splitting Tablets with Functional Scoring test.
1. Immediate-Release Tablets
Dissolution for immediate-release tablets is performed at the S2 stage (see USP <711>). Test 12 split tablet portions according to the specified Medium, Apparatus, Times, and Analysis.
Acceptance Criteria: The average of the 12 results is NLT Q, and no result is less than Q – 15%.
2. Extended Release Tablets
Perform dissolution testing of split tablet portions from extended-release tablets by one of the two alternative procedures. The procedure to be used is specified in the monograph.
Procedure 1 (Procedure for Extended-Release Dosage Forms, Dissolution USP <711>): Individually test 12 split tablet portions and 12 intact tablets.
Medium, Apparatus, and Analysis: As given in the monograph following the appropriate test number found on the labeling. Dissolution profile test time points are determined as follows. From the appropriate dissolution test in the monograph, use the time points given. At a minimum, use three time points with no more than one time point where the results exceed 85% dissolved.
Calculate the similarity factor ( f 2 ) for the intact-tablet results and the split-tablet portion results.
Acceptance Criteria: The calculated f 2 is NLT 50 (acceptable range: 50–100).
Procedure 2 (Procedure for Extended-Release Dosage Forms, Dissolution <711>): Use a split-tablet portion as the dosage unit. Individually test 12 dosage units.
Medium, Apparatus, Times, and Analysis: As given in the monograph following the appropriate test number found on the labeling.
Acceptance Criteria: The percentages of the labeled amount released at the times specified conform to the L2 level criteria of Acceptance Table 2 in USP <711>.
Disintegration
Disintegration testing is necessary only when used as a surrogate for dissolution testing as specified in the monograph. Follow the procedure using split portions from tablets that are acceptable according to the Splitting Tablets with Functional Scoring test as the dosage unit (see USP <701>).
New Products that do not meet the criteria should not have a scoring feature or any reference to scoring in the labelling.
Read also: List of USP General Chapters
