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A material sparing test to predict punch sticking during formulation development.
Drug Dev Ind Pharm. 2012 Sep; 38(9):1054-60.DD

Abstract

CONTEXT

A qualitative and material sparing test for punch sticking was developed as a predictive development screening tool for comparison of formulation strategies and processing methods to eliminate punch adhesion.

OBJECTIVE

To develop a predictive test for a formulation's potential to adhere to tablet punches during compression.

MATERIALS AND METHODS

Two proprietary compounds, A and B, with histories of punch sticking during manufacturing but not in development, were formulated with microcrystalline cellulose, lactose, croscarmellose sodium, and magnesium stearate. Matching placebos were also prepared by the same methods. Flat faced bevel edge (FFBE) punches of 1/2" diameter were compared with 1/4" SRC punches and 1/4" Flat Faced (FF) punches for adhesion potential using a Kilian rotary tablet press and a Huxley Bertram compaction simulator.

RESULTS AND DISCUSSION

Formulation accumulated on the punches after compression, which indicated potential for punch sticking that resulted in defective tablets with successive compactions. In all cases, only active formulations adhered to the FFBE and FF punches during tableting runs and with fewer compactions than the SRC punches. Those APIs were then reformulated and successfully manufactured using the predictive test results. Reducing the punch size to 1/4" permitted testing with 50 g of formulation, a ten-fold reduction in consumption compared to the 1/2" punches.

CONCLUSION

Flat surfaced punches were shown to be more challenging to adhesive formulations than SRC punches. Adhesive formulations were reformulated and successfully manufactured without punch sticking.

Authors+Show Affiliations

Three Rivers Community College, Norwich, CT 06360, USA. simmonsdsms@aol.comNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

22181042

Citation

Simmons, Daryl M., and Daniel S. Gierer. "A Material Sparing Test to Predict Punch Sticking During Formulation Development." Drug Development and Industrial Pharmacy, vol. 38, no. 9, 2012, pp. 1054-60.
Simmons DM, Gierer DS. A material sparing test to predict punch sticking during formulation development. Drug Dev Ind Pharm. 2012;38(9):1054-60.
Simmons, D. M., & Gierer, D. S. (2012). A material sparing test to predict punch sticking during formulation development. Drug Development and Industrial Pharmacy, 38(9), 1054-60. https://doi.org/10.3109/03639045.2011.637933
Simmons DM, Gierer DS. A Material Sparing Test to Predict Punch Sticking During Formulation Development. Drug Dev Ind Pharm. 2012;38(9):1054-60. PubMed PMID: 22181042.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A material sparing test to predict punch sticking during formulation development. AU - Simmons,Daryl M, AU - Gierer,Daniel S, Y1 - 2011/12/19/ PY - 2011/12/21/entrez PY - 2011/12/21/pubmed PY - 2013/1/15/medline SP - 1054 EP - 60 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 38 IS - 9 N2 - CONTEXT: A qualitative and material sparing test for punch sticking was developed as a predictive development screening tool for comparison of formulation strategies and processing methods to eliminate punch adhesion. OBJECTIVE: To develop a predictive test for a formulation's potential to adhere to tablet punches during compression. MATERIALS AND METHODS: Two proprietary compounds, A and B, with histories of punch sticking during manufacturing but not in development, were formulated with microcrystalline cellulose, lactose, croscarmellose sodium, and magnesium stearate. Matching placebos were also prepared by the same methods. Flat faced bevel edge (FFBE) punches of 1/2" diameter were compared with 1/4" SRC punches and 1/4" Flat Faced (FF) punches for adhesion potential using a Kilian rotary tablet press and a Huxley Bertram compaction simulator. RESULTS AND DISCUSSION: Formulation accumulated on the punches after compression, which indicated potential for punch sticking that resulted in defective tablets with successive compactions. In all cases, only active formulations adhered to the FFBE and FF punches during tableting runs and with fewer compactions than the SRC punches. Those APIs were then reformulated and successfully manufactured using the predictive test results. Reducing the punch size to 1/4" permitted testing with 50 g of formulation, a ten-fold reduction in consumption compared to the 1/2" punches. CONCLUSION: Flat surfaced punches were shown to be more challenging to adhesive formulations than SRC punches. Adhesive formulations were reformulated and successfully manufactured without punch sticking. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/22181042/A_material_sparing_test_to_predict_punch_sticking_during_formulation_development_ L2 - https://www.tandfonline.com/doi/full/10.3109/03639045.2011.637933 DB - PRIME DP - Unbound Medicine ER -