• Hetal Patel Maliba Pharmacy College, Uka Tarsadia University, Bardoli Mahuva Road, Surat, Gujarat, India 394350
  • Mukesh Gohel Research Director, Anand Pharmacy College, Gujarat, India


The demand for directly compressible co-processed excipients has increased mainly due to the availability of high-speed tableting machines, time-saving in filing abbreviated new drug applications (ANDA), simplified validation and stability of active pharmaceutical ingredient (API). The cost of new excipient development is very high as it demands toxicity study also. Hence, industry has focused on co-processing of approved materials. The main aim of co-processing is to obtain a product with added value related to the ratio of its functionality/price. The risk to product quality is reduced, and productivity is improved due to the use of multifunctional co-processed excipients. In the present era, the Quality by Design (QbD) concept is useful for the development of multifunctional co-processed excipients. Co-processing is not restricted to diluents. It can be extended to other ingredients such as binders and disintegrants of tablets and capsules. There is also scope for obtaining patents by working upon newer avenues of developing multifunctional co-processed excipient for lozenges (e. g. iso-melt of sugar) or for herbal excipients. The present review focuses on formulation and evaluation techniques of multifunctional co-processed excipients. The characteristics of currently available multifunctional co-processed materials are enlisted in the review to facilitate further research by research scholars and R & D scientists.

Keywords: Co-processed, Excipients, Oral drug delivery


1. Gupta H, Bhandari D, Sharma A. Recent trends in oral drug delivery: a review. Recent Pat Drug Delivery Formulation 2009; 3:162-73.
2. Gohel MC, Jogani PD, Bariya SH. Development of agglomerated directly compressible diluent consisting of brittle and ductile materials. Pharm Dev Technol 2003;8:143–51.
3. Gohel MC, Jogani PD. Functionality testing of multifunctional directly compressible adjuvant containing lactose, PVP and croscarmellose sodium. Pharm Technol North Am 2002;26:64-82.
4. Eraga SO, Arhewoh MI, Umwangho MU, Iwuagwu MA. Characterization of a novel, multifunctional, co-processed excipient and its effect on the release profile of paracetamol from tablets prepared by direct compression. Asian Pac J Trop Biomed 2015;5:768–72.
5. Marwaha M, Sandhu D, Marwaha R. Co-processing of excipients: a review on excipient development for improved tableting performance. Int J Appl Pharm 2010;2:41-7.
6. Gohel MC, Jogani PD. A review of co-processed directly compressible excipients. J Pharm Pharm Sci 2005;8:76-93.
7. Chougule AS, Dikpati A, Trimbake T. Formulation development techniques of co-processed excipients. J Adv Pharm Sci 2012;2:231-49.
8. Heinamaki J. New pharmaceutical excipients: development and regulatory perspectives. Available from: https:// crsnordic2012.hi.is/Welcome_files/Heinmki_Reykjavik.pdf. [Last accessed on 10 Aug 2012].
9. Goyanes A, Souto C, Martínez-Pacheco R. Co-processed MCC-Eudragit E excipients for extrusion–spheronization. Eur J Pharm Biopharm 2011;79:658–63.
10. Pharm Pro. The new era of functional excipients-an innovative approach in the design of dosage forms. Available from: http://www.pharmpro.com/articles/2011/05/raw-materials-functional-excipients. [Last accessed on 10 Aug 2012].
11. Patel S, Patel NM. Development of directly compressible co-processed excipient for dispersible tablets using 32 full factorial design. Int J Pharm Pharm Sci 2009;1:125-48.
12. Michoel A, Rombaut P, Verhoye A. Comparative evaluation of Co-processed lactose and microcrystalline cellulose with their physical mixtures in the formulation of folic acid tablets. Pharm Dev Technol 2002;7:79-87.
13. Pharma Tutor. Co-processed excipients: an overview of formulation aspects, physical characteristics and role as a pharmaceutical aid. Available from http:// www. pharmatutor.org/articles/overview-of-co-processed-pharmaceutical-excipients-formulation-aspects?page=0,2. [Last accessed on 10 Aug 2012].
14. Haware RV, Kancharla JP, Udupa AK, Staton S, Gupta MR, Al-Achi A, et al. Physico-mechanical properties of coprocessed excipient microce Lac® 100 by the DM3 approach. Pharm Res 2015;32:3618-35.
15. Buildersa PF, Bonaventurea AM, Tiwaladeb A, Okpakoc LC, Attamad AA. Novel multifunctional pharmaceutical excipients derived from microcrystalline cellulose–starch micro-particulate composites prepared by compatibilized reactive polymer blending. Int J Pharm 2010;388:159–67.
16. Nagendrakumar D, Raju SA, Shirsand SB, Para MS. Design of fast dissolving granisetron HCl tablets using novel co–processed super disintegrants. J Biosci Technol 2009;1:8-14.
17. Clerch AV, Campos FF, Pozo AD, Calpena Campmany AC. The pharmaceutical design of a new lactose-free co-processed excipient: application of hydrochlorothiazide as a low solubility drug model. Drug Dev Ind Pharm 2012;39:961-9.
18. Rojas J, Kumar V. Comparative evaluation of silicified microcrystalline cellulose II as a direct compression vehicle. Int J Pharm 2011;416:120–8.
19. Hauschild K, Picker KM. Evaluation of a new co-processed compound is based on lactose and maize starch for tablet formulation. AAPS PharmSci 2004;6:27-38.
20. Bowe KE. Recent advances in sugar-based excipients. Pharm Sci Technol Today 1998;1:166-73.
21. Patel H, Ghayal A, Mishra A. Formulation development of directly compressible co-processed excipient for sustained release of tramadol hydrochloride. J Pharm Investig 2015;45:51-63.
22. Parmar K, Vyas J, Patel N, Patel R. Study of excipients affecting dissolution profile of drug with special emphasis on co-processed excipients. Int J Pharm Res Scholars 2013;2:201-8.
23. Pusapati RJ, Kalyan Kumar MVR, Rapeti SS, Murthy TEGK. Development of co-processed excipients in the design and evaluation of atorvastatin calcium tablets by direct compression method. Int J Pharm Investig 2014;4:102–6.
24. David Schoneker. The Impact of excipient variability on QbD. Available from http://www.ich.org/fileadmin/Public_ Web_Site/Training/GCG__Endorsed_Training_Events/APEC_LSIF_JCCT_workshop_Beijing__China_Dec_08/Day_3/Impact_of_Excipient.pdf. (Last accessed on 20 Oct 2015].
25. Swarbrick J. ed. Encyclopedia of Pharmaceutical Technology. 3rd ed. New York: Informa healthcare; 2007.
26. Daraghmeh N, Chowdhry BZ, Leharne SA, Omari MM, Badwan AA. Co-processed chitin-mannitol as a new excipient for orodispersible tablets. Mar Drugs 2015;13:1739–64.
27. Muhammad A, Naqvi SBS, Gauhar S. Development of co-processed micro-granules for direct compression. Int J Pharm Pharm Sci 2011;3:64-9.
28. Gohel MC, Jogani PD. Exploration of melt granulation technique for the development of co-processed directly compressible adjuvant containing lactose and microcrystalline cellulose. Pharm Dev Technol 2003;8:175–85.
29. Kothiya M, Mehta K , Vadalia KR, Chavda J, Kapadiya S. Design and development of co-processed excipients for fast dissolving tablets of Irbesartan by melt agglomeration technique. J Pharm Investig 2015;45:163-86.
30. Uppuluri P, Chakraborty T, Devi VK, Raichur V. Preparation of novel co-processed excipient-study of flow properties and compatibility. Indo Am J Pharm Res 2014;4:5074-81.
31. United State Pharmacopoeia 32-National Formulatory 27. United States Pharmacopoeial Convention; 2008.
32. Tobyn MJ, McCarthy GP, Staniforth JN, Edge S. Physicochemical comparison between microcrystalline cellulose and silicified microcrystalline cellulose. Int J Pharm 1998;169:183–94.
33. Rojas J, Kumar V. Co-processing of cellulose II with amorphous silicon dioxide: effect of silicification on the powder and tableting properties. Drug Dev Ind Pharm 2012;38:209–26.
34. Starches D, Odeku OA, Schmid W, Picker-Freyer KM. Material and tablet properties of pregelatinized (thermally modified). Eur J Pharm Biopharm 2008;70:357–71.
35. Kittipongpatana OS, Kittipongpatana N. Preparation and physic-mechanical properties of co-precipitated rice starch-colloidal silicon dioxide. Powder Technol 2012;217:377–82.
36. Baykara T, Acarturk F. The effect of the binding agents on the friability and compressibility of granules. Drug Dev Ind Pharm 1989;15:1341-51.
37. Camargo JJR. Assessment of co-processing of cellulose II and silicon dioxide as a platform to enhance excipient functionality [PhD Thesis]. University of Iowa; 2012.
38. Oyi AR, Apeji YE, Musa H. Compact analysis of microcrystalline cassava starch-a direct compression binder. Niger J Pharm Sci 2009;8:59–65.
39. Aulton ME. ed. Pharmaceutics-The science of dosage forms. 2nd edition. USA: Churchill Livingstone; 2001.
40. Nachaegari SK, Bansal AK. Co-processed excipients for solid dosage forms. Pharm Technol 2004;28:52-64.
41. Gohel MC, Jogani PD. An investigation of direct compression characteristics of co-processed lactose-starch using factorial design. Indian J Pharm Sci 2003;65:31-8.
42. Bozkir A, Ozdemir N, Ozyurt C, Baykara T. Kinetic evaluation of the mechanical strength of briquette granules. Drug Dev Ind Pharm 1997;23:589-94.
43. ICH, Q1A (R2): Stability testing of new drug substances and products, International Conference on Harmonization, Geneva; 2003. p. 1-24.
44. Mehra DK, West KP, Wiggins JD, Inventors. FMC Corporation, assignee. coprocessed microcrystalline cellulose and calcium carbonate composition and its preparation and its preparation; 1988.
45. Ratnaraj S, Reilly WJ, Inventors. FMC corporation, assignee. Chewable pharmaceutical tablets; 1997.
46. Modliszewski JJ, Midwood DB, Ballards AD, Inventors. FMC Corporation, Applicant. Coprocessed galactomannan-glucomannan. WO 95/17831; 1999.
47. Norman GT, Nuguru KS, Amin AF, Chandar S. Inventors. Pharma, Inc., Morman GT, Nuguru KS, Amin AF, Chandar S. Applicants. Co-processed carbohydrate system as a quick-dissolve matrix for solid dosage forms. WO/2003/051338.
48. Schaible D, Mejias L, Inventors. JRS Pharma, Applicant. Orally Disintegrating Excipient. WO 2010/132431 A1.
49. Tewari D, Totova Y, Beissiner B, Durig T. Inventors. Hercules Incorporated, applicant. coprocessed silica coated polymer composition. WO 2014/165246 A1.
50. Bolhuis GK, Armstrong NA. Excipients for a direct compaction-an update. Pharm Dev Technol 2006;11:111–24.
51. Otilia K. Application challenges and examples of new excipients in advanced drug delivery systems. Am Pharm Rev 2011;14:60-8.
52. Forum tackles excipient quality and functionality. The international pharmaceutical excipients council Europe; 2015. Available from: http://ipeceurope.org/newsletter. asp?nlaid=734&nlid=53. [Last accessed on 15 Sep 2015].
53. Custom Market Research Services. Available from: http://www.marketsandmarkets.com/Market-Reports/pharma-excipients-market-956.html. [Last accessed on 15 Sep 2015].
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How to Cite
Patel, H., & Gohel, M. (2016). A REVIEW ON DEVELOPMENT OF MULTIFUNCTIONAL CO-PROCESSED EXCIPIENT. Journal of Critical Reviews, 3(2), 48-54. Retrieved from https://innovareacademics.in/journals/index.php/jcr/article/view/11811
Pharmaceutical Sciences