PMID- 15496044
OWN - NLM
STAT- MEDLINE
DCOM- 20041221
LR  - 20220318
IS  - 1544-3191 (Print)
IS  - 1086-5802 (Linking)
VI  - 44
IP  - 5
DP  - 2004 Sep-Oct
TI  - Variability in tablet fragment weights when splitting unscored cyclobenzaprine 10 
      mg tablets.
PG  - 583-6
AB  - OBJECTIVE: To determine the weight variation and calculated dosing variability of 
      tablet fragments upon splitting unscored cyclobenzaprine hydrochloride 10 mg 
      tablets using two common tablet splitting devices. DESIGN: Comparative 
      pharmaceutics study. SETTING: Pharmacy school laboratory. PARTICIPANTS: Not 
      applicable. INTERVENTIONS: Unscored cyclobenzaprine hydrochloride 10 mg tablets 
      from one generic manufacturer were split with a tablet splitter or a kitchen 
      knife by a licensed pharmacist and two doctor of pharmacy students (n = 15 
      tablets for each method per participant). MAIN OUTCOME MEASURES: Fragment weights 
      (FWs) were compared with the theoretical weights (TWs), which were calculated as 
      one half of the mean weight of the tablets used in each part of the experiment; 
      means, relative standard deviations (RSDs), and percentages of TW were also 
      calculated. RESULTS: The mean weight before splitting the 45 tablets with the 
      tablet splitter was 136.6 +/- 2.1 mg (TW = 68.3 mg). The mean FW after splitting 
      was 67.9 +/- 7.9 mg. The RSD of 11.6% corresponded to a range of 69.4% to 130.2% 
      of the TW and an estimated drug content of the split fragments between 3.47 mg 
      and 6.51 mg. The mean weight before splitting the 45 tablets cut with a kitchen 
      knife was 136.6 +/- 2.0 mg (TW = 68.3 mg). The mean FW was 68.0 +/- 15.7 mg with 
      a RSD of 23.2%, corresponding to a range of 49.9% to 149.5% of the TW and an 
      estimated drug content of the split fragments between 2.49 mg and 7.48 
      CONCLUSION: Tablet fragments obtained after splitting this generic 
      cyclobenzaprine 10 mg product varied considerably in weight and estimated drug 
      content. Accordingly, splitting cyclobenzaprine 10 mg tablets to achieve 5 mg 
      doses could result in unpredictable dosing and therapeutic response.
FAU - Cook, Thomas J
AU  - Cook TJ
AD  - Department of Pharmaceutics, Ernest Mario School of Pharmacy, Rutgers, The State 
      University of New Jersey, 160 Frelinghuysen Road, Piscataway, NJ 08854, USA. 
      tjcook@rci.rutgers.edu
FAU - Edwards, Shanya
AU  - Edwards S
FAU - Gyemah, Charlene
AU  - Gyemah C
FAU - Shah, Manoj
AU  - Shah M
FAU - Shah, Indu
AU  - Shah I
FAU - Fox, Tiziana
AU  - Fox T
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Am Pharm Assoc (2003)
JT  - Journal of the American Pharmacists Association : JAPhA
JID - 101176252
RN  - 0 (Tablets)
RN  - 0 (Tranquilizing Agents)
RN  - 1806D8D52K (Amitriptyline)
RN  - 69O5WQQ5TI (cyclobenzaprine)
SB  - IM
MH  - Amitriptyline/*analogs & derivatives
MH  - Drug Compounding/*methods
MH  - *Tablets
MH  - Tranquilizing Agents
EDAT- 2004/10/22 09:00
MHDA- 2004/12/22 09:00
CRDT- 2004/10/22 09:00
PHST- 2004/10/22 09:00 [pubmed]
PHST- 2004/12/22 09:00 [medline]
PHST- 2004/10/22 09:00 [entrez]
AID - S1544-3191(15)31789-1 [pii]
AID - 10.1331/1544-3191.44.5.583.cook [doi]
PST - ppublish
SO  - J Am Pharm Assoc (2003). 2004 Sep-Oct;44(5):583-6. doi: 
      10.1331/1544-3191.44.5.583.cook.