Binder – Pharmaceutical Excipients

Binder Excipients in the Pharmaceutical Industry

Binders play an important role in the tableting process of pharmaceuticals. They are used to improve the cohesion and plasticity of the powder mixture, which enhances the processability of the tablet and reduces the risk of tablet breakage during manufacture.

Peter C. Schmidt in Pharmazeutische Hilfsstoffe (1) explains binders: “From a technological point of view, pharmaceutical binders are “adhesives” designed to perform the following tasks: Increasing the particle size and, as a result, improving the flowability, reducing the bulk volume and the dust content of the mass to be processed, and, in the case of further processing into tablets or pellets, improving the plastic deformability.”

The quantity of binder excipient used in the tableting process varies depending on the specific application, but typically ranges from 2-10% of the tablet weight.

Binder
Binder

Binder are distinct from fillers and diluents, which have different functions in the tablet. Fillers are added to increase the bulk of the tablet, while diluents are added to reduce the potency of the active ingredient. Binder excipients, on the other hand, are added specifically to improve the tablet’s mechanical properties.

Binders can be of different origins and divided into (1)

  • Natural Polymers: Arabic gum, Gelatin, Sodium Alginate, Pullulan, Starch, Pregelatinized Starch and Tragant
  • Semi-Synthetic Polymers: Carboxymethylcellulose Sodium, Dextrin, Hydroxyethylcellulose, Hydroxypropylcellulose, Hypromellose, Maltodextrin, Methylcellulose
  • Synthetic Polymers: Copovidone, Macrogols, Polyvinyl Alcohols (PVA), Povidone,
  • Polymers with sustained release properties: Amino methacrylat-Copolymer (Type A), Amino methacrylat-Copolymer (Typ B), Celluloseacetate, Celluloseacetatbutyrate, Chitosan, Ethylcellulose, Polyacrylat-Dispersion 30 %, Poly(vinylacetat), Poly(vinylacetat)-Dispersion 30, Schellack, Zein
  • Other Binders with sustained release properties: Fatty alcohols, Fat and Waxes, Hydrated Rizinius Oil, Stearic Acid

Many excipients can be used as binders. The main ones are

  1. Povidone (Polyvinylpyrrolidone, PVP)
  2. Hydroxypropyl cellulose (HPC)
  3. Microcrystalline cellulose (MCC)
  4. Polyethylene glycol (PEG)
  5. Gelatin
  6. Starch
  7. Carbomers
  8. Sodium carboxymethyl cellulose (NaCMC)

Definitions According to the European Pharmacopeia (Ph. Eur.) and USP/NF

  1. Povidone (Polyvinylpyrrolidone, PVP) Ph. Eur.: A water-soluble polymer that can be used as a binder excipient in tablet formulations. USP/NF: A water-soluble polymer that is used as a binder, lubricant, and disintegrant in tablet and capsule formulations.
  1. Hydroxypropyl cellulose (HPC) Ph. Eur.: A semi-synthetic cellulose derivative that is used as a binder, thickener, and emulsifier in pharmaceutical formulations. USP/NF: A cellulose derivative that is used as a binder, lubricant, and disintegrant in tablet and capsule formulations.
  1. Microcrystalline cellulose (MCC) Ph. Eur.: A purified form of cellulose that is used as a filler and diluent in tablet formulations. USP/NF: A purified form of cellulose that is used as a filler and diluent in tablet and capsule formulations.
  1. Polyethylene glycol (PEG) Ph. Eur.: A water-soluble polymer that can be used as a binder excipient in tablet formulations. USP/NF: A water-soluble polymer that is used as a lubricant and solubilizing agent in pharmaceutical formulations.
  1. Gelatin Eur.: A protein derived from collagen that is used as a binder and gelling agent in pharmaceutical formulations. USP/NF: A protein derived from collagen that is used as a binder and gelling agent in tablet and capsule formulations.
  1. Starch Eur.: A polysaccharide that is used as a binder and disintegrant in tablet formulations. USP/NF: A polysaccharide that is used as a binder, disintegrant, and thickener in tablet and capsule formulations.
  1. Carbomers Eur.: A family of water-soluble polymers that are used as thickening and emulsifying agents in pharmaceutical formulations. USP/NF: A family of water-soluble polymers that are used as thickening and emulsifying agents in topical and oral pharmaceutical formulations.
  1. Sodium carboxymethyl cellulose (NaCMC) Ph. Eur.: A cellulose derivative that is used as a binder and disintegrant in tablet formulations. USP/NF: A cellulose derivative that is used as a binder and thickener in pharmaceutical formulations.

In conclusion, binder excipients are essential components in the tableting process of pharmaceuticals. They improve the cohesion and plasticity of the powder mixture, enabling the manufacture of robust and uniform tablets. Binder excipients differ from fillers and diluents, which serve different functions in tablet formulations. A variety of excipients, including povidone, hydroxypropyl cellulose, microcrystalline cellulose, polyethylene glycol, gelatin, starch, carbomers, and sodium carboxymethyl cellulose, are commonly used in the pharmaceutical industry. The definitions of these excipients according to the European Pharmacopeia and USP/NF reflect their various applications in pharmaceutical formulations.

Binder Excipients on pharmaexcipients.com – in alphabetical order

Product  Manufacturer
AVICEL RC-591 DuPont
Benecel MC Ashland
BonuCel D 3 H 2910 BIOGRUND GmbH
Bonutab® BIOGRUND GmbH
CompactCel® BIOGRUND GmbH
CompactCel® natural BIOGRUND GmbH
CompactCel® organic BIOGRUND GmbH
CompactCel® SIL BIOGRUND GmbH
COMPACTROL® JRS Pharma
CORN STARCH 400L-NF Roquette
DEXTROSE MONOHYDRATE F Roquette
DEXTROSE MONOHYDRATE G Roquette
DEXTROSE MONOHYDRATE GD-SDG Roquette
DEXTROSE MONOHYDRATE M Roquette
DEXTROSE MONOHYDRATE SF Roquette
DI-CAFOS® A 12 Budenheim
DI-CAFOS® D 14 Budenheim
DiCom® PL009 P60 Gangwal Healthcare – Pharma Excipients
EMCOCEL® 50 M  JRS Pharma
EMCOCEL® 90 M  JRS Pharma
EMCOCEL® 90 M COARSE  JRS Pharma
EMCOCEL® HD 90  JRS Pharma
EMCOCEL® LP 200  JRS Pharma
EMCOCEL® XLM 90  JRS Pharma
EMDEX®  JRS Pharma
FLORITE® PS-10 Tomita Pharmaceutical
FLORITE® PS-200 Tomita Pharmaceutical
FLORITE® R Tomita Pharmaceutical
galenIQ™ 720 BENEO
galenIQ™ 721 BENEO
Gelucire 44/14 Gattefosse
Gelucire 50/13 Gattefosse
Hicel 50M Sigachi
Hicel 90M Sigachi
Hicel LP 200 Sigachi
Hicel SMCC 90M (silicified MCC) Sigachi
Hicel SMCC HD 90M (silicified MCC) Sigachi
Hicel XLM 90 Sigachi
Klucel EF, EXF Pharm Ashland
Klucel ELF Pharm Ashland
Kollicoat® IR BASF
Kollidon® 25 BASF
Kollidon® 30 Origin China BASF
Kollidon® 30 Origin Germany BASF
Kollidon® 30 Origin USA BASF
Kollidon® CL-SF BASF
Kollidon® VA 64 Fine BASF
Kolliphor® P 338 BASF
Kollitab™ DC 87 L BASF
LUBRITAB® JRS Pharma
Ludiflash® BASF
Ludipress® BASF
Ludipress® LCE BASF
LYCATAB® C Roquette
LYCATAB® C LM Roquette
LYCATAB® CT Roquette
LYCATAB® DSH Roquette
LYCATAB® PGS Roquette
LYCOAT® NG 70 Roquette
LYCOAT® RS 720 Roquette
LYCOAT® RS 780 Roquette
MAIZE STARCH 5% Roquette
MAIZE STARCH AMYLO N-400 Roquette
MAIZE STARCH B Roquette
MAIZE STARCH EXTRA WHITE Roquette
MAIZE WAXY STARCH N-200 Roquette
PEA STARCH N-735 Roquette
Plasdone Povidone Roquette
POTATO STARCH 6% Roquette
POTATO STARCH 8% Roquette
POTATO STARCH SUPRA NP Roquette
Powdered GP-USP Roquette
POWDERED NF CORN STARCH Roquette
PROSOLV® EASYtab NUTRA CM JRS Pharma
PROSOLV® EASYtab NUTRA GM JRS Pharma
PROSOLV® SMCC 50 LD JRS Pharma
SCORALITE DC 90MD ICL
SCORALITE LL 250 ICL
SheffCel 60HD Kerry
SheffCel 65HD Kerry
StarLac® Roquette
STARLOSE® Gangwal Healthcare Private Limited
Sucrose EMPROVE® ESSENTIAL Ph Eur,BP,ChP,JP,NF Merck KGaA
TABLETTOSE 100 Meggle
TABLETTOSE 70 Meggle
TABLETTOSE 80 Meggle
TACKIDEX® B 147 Roquette
TACKIDEX® B 167 Roquette
TRI-CAFOS® 250 Budenheim
VIVAPHARM® HPMC E 15 JRS Pharma
VIVAPHARM® HPMC E 3 JRS Pharma
VIVAPHARM® HPMC E 5 JRS Pharma
VIVAPHARM® HPMC E 50 JRS Pharma
VIVAPHARM® HPMC E 6 JRS Pharma
VIVAPHARM® PVA 05 fine JRS Pharma
VIVAPHARM® PVP K25 JRS Pharma
VIVAPHARM® PVP K30 JRS Pharma
VIVAPHARM® PVP/VA 64 JRS Pharma
WHEAT STARCH TB Roquette

References
(1) „Pharmazeutische Hilfsstoffe“ Peter C. Schmidt · Siegfried Lang