Tags

Type your tag names separated by a space and hit enter

Tablet formulation of an active pharmaceutical ingredient with a sticking and filming problem: direct compression and dry granulation evaluations.
Drug Dev Ind Pharm. 2015 Feb; 41(2):333-41.DD

Abstract

OBJECTIVE

To develop a tablet formulation for an active pharmaceutical ingredient for which sticking and filming problems occurred during tablet punching.

METHODS

Direct compression and dry granulation tableting techniques were evaluated using factorial experimental design. The effects of chrome-coated punch tips, filler types and active percent in the tablet formulation by direct compression were evaluated. Similarly, for dry granulation using the roller compaction technique, three formulation factors - roller compaction pressure, intragranular filler percent and filler type - were studied. Tablets prepared by both techniques were characterized in regard to their compressibility index, tablet hardness, disintegration time, friability index and stickiness-filming index (an arbitrary index). Ten formulations were prepared by each technique. Using multiple response optimizations and estimated response surface plots, the data were analyzed to identify optimum levels for the formulation factors.

RESULTS

Compressibility index values for all the formulations prepared by direct compression exceeded 25%, unlike the blends prepared by dry granulation. Both tablet hardness and disintegration time for direct compression formulations were significantly lower than for dry granulation formulations. The friability index values were significantly higher for direct compression formulations than for dry granulation formulations. All the direct compression formulations, unlike the dry granulation formulations, had a high stickiness-filming index.

CONCLUSION

Statistical analysis helped in identifying the optimum levels of formulation factors, as well as the method for eliminating sticking and filming. Unlike the direct compression technique, dry granulation yielded tablets for which sticking and filming were completely eliminated.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Bejugam NK
SRI International , Menlo Park, CA , USA.
Mutyam SK
No affiliation info available
Shankar GN
No affiliation info available

MeSH

CelluloseChemistry, PharmaceuticalCompressive StrengthExcipientsHardnessHumansTablets

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

24279424

Citation

Bejugam, Naveen K., et al. "Tablet Formulation of an Active Pharmaceutical Ingredient With a Sticking and Filming Problem: Direct Compression and Dry Granulation Evaluations." Drug Development and Industrial Pharmacy, vol. 41, no. 2, 2015, pp. 333-41.
Bejugam NK, Mutyam SK, Shankar GN. Tablet formulation of an active pharmaceutical ingredient with a sticking and filming problem: direct compression and dry granulation evaluations. Drug Dev Ind Pharm. 2015;41(2):333-41.
Bejugam, N. K., Mutyam, S. K., & Shankar, G. N. (2015). Tablet formulation of an active pharmaceutical ingredient with a sticking and filming problem: direct compression and dry granulation evaluations. Drug Development and Industrial Pharmacy, 41(2), 333-41. https://doi.org/10.3109/03639045.2013.859266
Bejugam NK, Mutyam SK, Shankar GN. Tablet Formulation of an Active Pharmaceutical Ingredient With a Sticking and Filming Problem: Direct Compression and Dry Granulation Evaluations. Drug Dev Ind Pharm. 2015;41(2):333-41. PubMed PMID: 24279424.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tablet formulation of an active pharmaceutical ingredient with a sticking and filming problem: direct compression and dry granulation evaluations. AU - Bejugam,Naveen K, AU - Mutyam,Shravan K, AU - Shankar,Gita N, Y1 - 2013/11/27/ PY - 2013/11/28/entrez PY - 2013/11/28/pubmed PY - 2015/11/4/medline KW - Direct compression KW - dry granulation KW - roller compaction KW - statistical design KW - stickiness KW - tablets SP - 333 EP - 41 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 41 IS - 2 N2 - OBJECTIVE: To develop a tablet formulation for an active pharmaceutical ingredient for which sticking and filming problems occurred during tablet punching. METHODS: Direct compression and dry granulation tableting techniques were evaluated using factorial experimental design. The effects of chrome-coated punch tips, filler types and active percent in the tablet formulation by direct compression were evaluated. Similarly, for dry granulation using the roller compaction technique, three formulation factors - roller compaction pressure, intragranular filler percent and filler type - were studied. Tablets prepared by both techniques were characterized in regard to their compressibility index, tablet hardness, disintegration time, friability index and stickiness-filming index (an arbitrary index). Ten formulations were prepared by each technique. Using multiple response optimizations and estimated response surface plots, the data were analyzed to identify optimum levels for the formulation factors. RESULTS: Compressibility index values for all the formulations prepared by direct compression exceeded 25%, unlike the blends prepared by dry granulation. Both tablet hardness and disintegration time for direct compression formulations were significantly lower than for dry granulation formulations. The friability index values were significantly higher for direct compression formulations than for dry granulation formulations. All the direct compression formulations, unlike the dry granulation formulations, had a high stickiness-filming index. CONCLUSION: Statistical analysis helped in identifying the optimum levels of formulation factors, as well as the method for eliminating sticking and filming. Unlike the direct compression technique, dry granulation yielded tablets for which sticking and filming were completely eliminated. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/24279424/Tablet_formulation_of_an_active_pharmaceutical_ingredient_with_a_sticking_and_filming_problem:_direct_compression_and_dry_granulation_evaluations_ DB - PRIME DP - Unbound Medicine ER -