E NUTRI SPERSE NUTRISPUTRI SPERSE NUTRI SPERSE SPERSE NUTRI SPERSE NUTRISP

NUTRISPERSE NUTRI SPERSE NUTRI SPERSE NU-SPERSE NUTRI SPERSE NUTRI SPERSE NUTRI SPERSEUTRI SPERSE NUTRI SPERSE NUTRI SPERSE NUTRI SPERSE NUTRI SPERSE NUTRI SPERSE NUTRISPERSE NUTRISPERSE NU-

PERSE NUTRI SPERSE NUTRI SPERSE NUTRI SPERSE NUTRI SPERSE NUTRI SPERSE NUTRI SPERSE NUTRI SPERSE NUTRI SPERSE NUTRI

Powdered Lipids

STEROTEX® NFLubricating Dry Binder

ABITEC Corporation501 W. 1st Ave.Columbus, OH 43215 USA

800-555-1255+1 614-429-6464www.abiteccorp.comsales@abiteccorp.com

LUBRICATING DRY BINDER FOR DIRECT COMPRESSION TABLETINGSTEROTEX NF (Hydrogenated Vegetable Oil Type I) functions both as a boundary lubricant and as a dry binder. The oleaginous nature of Sterotex NF provides boundary lubrication to direct-compression tableting blends reducing ejection force. Sterotex NF also plastically deforms at relatively low compression pressures providing increased tablet hardness and reduced tablet friability making it an ideal dry binder for direct compression tableting operations.

PRIMARY ADVANTAGES:• Freely flowing• Plastically deforming at low compression pressures• Provides boundary lubrication and reduces ejection force• Economical compared to other dry binders• Reduced effect on disintegration times compared with magnesium stearate

STEROTEX® NF

Application 1: Partial Magnesium Stearate Replacement

ABITEC CORPORATION | 501 W. First Ave, Columbus, OH 43215 | www.abiteccorp.com

STEROTEX® is a registered trademark of ABITEC Corporation. All information and statements given in this brochure are believed to be accurate at the time of publication. However, neither ABITEC Corporation nor any of their affiliates make any representations or warranty with respect thereto, including, but not limited to, any results obtained in the processing of the products by customers or any third party. All information and statements are intended for persons having the required skill and know-how and do not relieve the customer or user from verifying the suitability of infor-mation and statements given for a specific purpose prior to use of the products. It is entirely the obligation of the customer or user to comply with applicable laws and regulations, and also with all patent or other intellectual property rights of third parties. ABITEC CORPORATION EXPRESSELY DISCLAIMS ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, WHETHER EXPRESSED OR IMPLIED, AS TO THE ACCURACY, CURRENCY, COMPLETENESS AND/OR THE MERCHANTABILITY OR FITNESS OF A PARTICULAR PURPOSE OF ANY INFORMATION CONTAINED IN THIS BROCHURE AND/OR PRODUCT DESCRIBED OR PROMOTED IN THIS BROCHURE, INCLUDING WARRATNTIES WITH RESPECT TO INFRINGEMENT OF ANY PATENT, COPYRIGHT, OR OTHER RIGHTS OF A THIRD PARTY. We reserve the right to change product specification and it specified properties of the products without prior notice.

Application 2: Dry Binding

497 471

465 453

464 449

432 433 429

464

403

469

428

449 426

329 317

365 380

393

261

335 325

356 370

0

100

200

300

400

500

600

0 2 4 6 8 10 12 14 16

USP

/EP

Disi

nteg

rato

n Ti

me

(sec

)

Hardness (kP)

USP/EP Disintegration Time

Sterotex NF 0.00% Sterotex NF 0.75% Sterotex NF 1.50% Sterotex NF 2.25% Sterotex NF 3.00%

Tablet Manufacturing Formula: Spray-dried Mannitol (85.5%), MCC-102 (9.5%) Lubricants (SNF+mgst = 5.0% ) Tablet Weight = 1000mg Tablet Press = Manesty Beta Press Press Speed = 50rpm (dwell time 10 msec) Punches = 0.625" FFBE Type "B"

44.5

53.4

84.55

93.45

111.25

57.85

71.2

93.45

102.35

111.25

62.3

75.65

93.45

111.25

129.05

62.3

75.65

93.45

111.25

124.6

62.3

80.1

97.9

106.8

124.6

0

20

40

60

80

100

120

140

0 5 10 15 20 25

Ejec

tion

forc

e (N

)

Compression force (kN)

Ejection Force

Sterotex NF 0.00% Sterotex NF 0.75% Sterotex NF 1.50% Sterotex NF 2.25% Sterotex NF 3.00%

Tablet Manufacturing Formula: Spray-dried Mannitol (85.5%), MCC-102 (9.5%) Lubricants (SNF+mgst = 5.0% ) Tablet Weight = 1000mg Tablet Press = Manesty Beta Press Press Speed = 50rpm (dwell time 10 msec) Punches = 0.625" FFBE Type "B"

6.9

9.1

11.4

13.5

14.6

5.9

8.1

10.4

12.3

13.9

6.2

8.5

10.8

12.9

14.4

0

2

4

6

8

10

12

14

16

18

0 5 10 15 20

Hard

ness

(kP)

Compression Force (kN)

Compaction (5.0% w/w of dry binder)

Sterotex NF Copovidone Hydroxypropyl Cellulose

Tablet Manufacturing Formula: Spray-dried Mannitol (83.25%), MCC-102 (9.25%) magnesium stearte (2.5%), and dry-binder (5.0%) Tablet Weight = 1000mg Tablet Press = Manesty Beta Press Press Speed = 50rpm (dwell time 10 msec) Punches = 0.625" FFBE Type "B"

0.412

0.203

0.13

0.181

0.114

0.465

0.236

0.144

0.087 0.096

0.053

0.151

0

0.059

0.151

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

0 5 10 15 20 25

Fria

bilit

y (%

)

Compression Force (kN)

Friability (Dry Binder 5.0% w/w)

Sterotex NF Copovidone Hydroxypropyl Cellulose Tablet Manufacturing

Formula: Spray-dried Mannitol (83.25%), MCC-102 (9.25%) magnesium stearte (2.5%), and dry-binder (5.0%) Tablet Weight = 1000mg Tablet Press = Manesty Beta Press Press Speed = 50rpm (dwell time 10 msec) Punches = 0.625" FFBE Type "B"