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Cellulose, Powdered

C 1 Nonproprietary Names
BP: Powdered Cellulose
Powdered cellulose has been investigated as an alternative to
microcrystalline cellulose as an agent to assist the manufacture of
pellets by extrusion/spheronization.(2,3) However, powdered cellu-
JP: Powdered Cellulose lose alone requires too much water and due to water movement
PhEur: Cellulose, Powdered during extrusion cannot be used as an extrusion/spheronization aid
USP-NF: Powdered Cellulose on its own.(4)
Powdered cellulose is also used widely in cosmetics and food
2 Synonyms products as an adsorbent and thickening agent.
Alpha-cellulose; Arbocel; cellulosi pulvis; E460; Elcema; KC Flock;
Table I: Uses of powdered cellulose.
Microcel 3E-150; Sanacel; Sanacel Pharma; Sancel-W; Solka-Floc.
Use Concentration (%)
3 Chemical Name and CAS Registry Number
Capsule filler 5–30
Cellulose [9004-34-6] Tablet binder 5–40 (wet granulation)
10–30 (dry granulation)
4 Empirical Formula and Molecular Weight Tablet disintegrant 5–20
Tablet glidant 1–2
(C6H10O5)n 243 000 where n  500.
Since cellulose is derived from a natural polymer, it has variable
chain length and thus variable molecular weight. See also Sections 8
and 13. 8 Description
Powdered cellulose occurs as a white or almost white, odorless and
5 Structural Formula tasteless powder of various particle sizes, ranging from a free-
flowing fine or granular dense powder, to a coarse, fluffy,
nonflowing material.

9 Pharmacopeial Specifications
See Table II. See also Section 18.

Table II: Pharmacopeial specifications for powdered cellulose.

Test JP XV PhEur 6.3(a) USP32–NF27


(b)
Identification þ þ þ
Characters þ þ —
Microbial limits
Aerobic 4103 cfu/g 4103 cfu/g 4103 cfu/g
Fungi and yeast 4102 cfu/g 4102 cfu/g 4102 cfu/g
pH (10% w/w suspension) 5.0–7.5 5.0–7.5 5.0–7.5
Loss on drying 46.5% 46.5% 46.5%
Residue on ignition 40.3% 40.3% 40.3%
Solubility — þ —
Ether-soluble substances 415.0 mg 40.15% 415.0 mg
6 Functional Category Water-soluble substances 415.0 mg 41.5% 415.0 mg
Adsorbent; glidant; suspending agent; tablet and capsule diluent; Heavy metals 410 ppm 410 ppm 40.001%
tablet disintegrant; thickening agent. (a) The PhEur 6.3 also includes crystallinity, particle size distribution and powder flow
under functionality-related characteristics.
7 Applications in Pharmaceutical Formulation or (b) Degree of polymerization is 5440 for JP XV, PhEur 6.3 and USP32–NF27.
Technology
Powdered cellulose is used as a tablet diluent and filler in two-piece 10 Typical Properties
hard capsules; see Table I. In both contexts it acts as a bulking agent Angle of repose
to increase the physical size of the dosage form for formulations <628 for Arbocel M80;
containing a small amount of active substance. <498 for Arbocel P 290;
Powdered cellulose has acceptable compression properties,
although the flow properties of most brands are poor. However, <368 for Arbocel A 300.
low-crystallinity powdered cellulose has exhibited properties that Density (bulk) 0.15–0.39 g/cm3, depending on the source and
are different from standard powdered cellulose materials, and has grade.
shown potential as a direct-compression excipient.(1) Density (tapped) 0.21–0.48 g/cm3, depending on the source and
In soft gelatin capsules, powdered cellulose may be used to grade.
reduce the sedimentation rate of oily suspension fills. It is also used Density (true)
as the powder base material of powder dosage forms, and as a 1.47–1.51 g/cm3 (5) depending on source and grade;
suspending agent in aqueous suspensions for peroral delivery. It 1.27–1.61 g/cm3 (6) depending on source and grade.
may also be used to reduce sedimentation during the manufacture of Moisture content Powdered cellulose is slightly hygroscopic;(7) see
suppositories. Figures 1 and 2.

1 36
Cellulose, Powdered 13 7

10000 × [2nd deriv. log(1/R)]


20 3.0 2293 0.3
2245
1891 2404
1401 2019
Equilibrium moisture at 25°C (%)
16
0.0

log(1/R)
1481
1428 1590
1707
2106
C
12 2335

1921 2485

8 2273
−5.0 −0.2
1100 1300 1500 1700 1900 2100 2300 2500
Wavelength/nm
4

Figure 3: Near-infrared spectrum of powdered cellulose measured by


reflectance.
0
0 10 20 30 40 50 60 70 80 90 100 Table III: Particle size distribution of selected commercially available
powdered cellulose.
Relative humidity (%)
Grade Average particle size (mm)
Powdered cellulose (Solka-Floc BW-40, Lot no. 8-10-30A)
Powdered cellulose (Solka-Floc BW-20, Lot no. 22A-19) Arbocel M80 60
Powdered cellulose (Solka-Floc Fine Granular, Lot no. 9-10-8) Arbocel M80 80
Arbocel A 300 250
KC Flock W–50 45
Figure 1: Equilibrium moisture content of powdered cellulose at 258C. KC Flock W–100G 37
KC Flock W–200G 32
20 KC Flock W–250 30
KC Flock W–300G 28
KC Flock W–400G 24
Equilibrium moisture at 25°C (%)

Solka–Floc 900 NF 110


16 Solka–Floc 20 NF 100
Solka–Floc 40 NF 60

12 11 Stability and Storage Conditions


Powdered cellulose is a stable, slightly hygroscopic material.(7) The
bulk material should be stored in a well-closed container in a cool,
8 dry place.

12 Incompatibilities
Incompatible with strong oxidizing agents, bromine pentafluoride,
4 sodium nitrite and fluorine.(6)

13 Method of Manufacture
0 Powdered cellulose is manufactured by the purification and
0 10 20 30 40 50 60 70 80 90 100 mechanical size reduction of a-cellulose obtained as a pulp from
Relative humidity (%) fibrous plant materials.

Powdered cellulose (Solka-Floc BW-100, Lot no. 9-7-18B) 14 Safety


Powdered cellulose (Solka-Floc BW-200, Lot no. 22A-20)
Powdered cellulose (Solka-Floc Fine BW-2030, Lot no. 240) Powdered cellulose is widely used in oral pharmaceutical formula-
tions and food products and is regarded as a nontoxic and
nonirritant material. However, allergic reactions when inhaled,
Figure 2: Equilibrium moisture content of powdered cellulose at 258C. ingested or in contact with the skin are possible.(6)
Powdered cellulose is not absorbed systemically following
NIR spectra see Figure 3. peroral administration and thus has little toxic potential. Con-
Particle size distribution sumption of large quantities of cellulose may, however, have a
Powdered cellulose is commercially available in several different laxative effect, although this is unlikely to be a problem when
particle sizes; see Table III. cellulose is used as an excipient in pharmaceutical formulations.
Solubility Practically insoluble in water, dilute acids, and most Deliberate abuse of formulations containing cellulose, either by
organic solvents, although it disperses in most liquids. Slightly inhalation or by injection, has resulted in the formation of cellulose
soluble in 5% w/v sodium hydroxide solution. Powdered granulomas.(8)
cellulose does not swell in water, but does so in dilute sodium LD50 (rat, oral): >5 g/kg (6)
hypochlorite (bleach). LD50 (rat, inhalation): 5.8 g/m3/4 h (6)