Third Panel

Use this guide to help simplify the tablet formulation process by selecting the four API Criteria above.
IDEAL PROCESS:
Direct Compression
CHALLENGES:
No Particular Challenge

RECOMMENDED EXCIPIENTS
Binder:
No Binder Needed
Filler/Binder:
One of the following
Disintegrant:
Lubricant:
OR

ADDITIONAL INFO / COMMENTS

Select filler/binder grade according to API's particle size distribution. When using PROSOLV® EASYtab, add more disintegrant and lubricant, if needed.

IDEAL PROCESS:
Direct Compression
CHALLENGES:
Dissolution

RECOMMENDED EXCIPIENTS
Binder:
No Binder Needed
Filler/Binder:
One of the following
Disintegrant:
One of the following
Lubricant:
OR

ADDITIONAL INFO / COMMENTS

Select filler/binder grade according to API's particle size distribution. PROSOLV® EASYtab, add more disintegrant and lubricant, if needed

IDEAL PROCESS:
Wet Granulation (Fluid Bed)
CHALLENGES:
Compaction

RECOMMENDED EXCIPIENTS
Filler/Binder:
Disintegrant:
Lubricant:
IDEAL PROCESS:
Wet Granulation (Fluid Bed)
CHALLENGES:
Compaction Dissolution

RECOMMENDED EXCIPIENTS
Filler/Binder:
Disintegrant:
Lubricant:

ADDITIONAL INFO / COMMENTS

Use VIVASOL® extragranularly and other disintegrants in the granules.

IDEAL PROCESS:
Roller Compaction
CHALLENGES:
Powder Flow

RECOMMENDED EXCIPIENTS
Filler/Binder:
Blend of
Disintegrant:
Lubricant:

ADDITIONAL INFO / COMMENTS

Use part of the binder extragranularly.

IDEAL PROCESS:
Roller Compaction
CHALLENGES:
Powder Flow Dissolution

RECOMMENDED EXCIPIENTS
Filler/Binder:
Blend of
Disintegrant:
Lubricant:

ADDITIONAL INFO / COMMENTS

Use part of the binder extragranularly. Use VIVASOL® extragranularly and other disintegrants in the granules.

IDEAL PROCESS:
Wet Granulation (High Shear)
CHALLENGES:
Powder Flow Compaction

RECOMMENDED EXCIPIENTS
Filler/Binder:
Intragranular Blend of
Extragranular
Disintegrant:
Lubricant:
IDEAL PROCESS:
Wet Granulation (High Shear)
CHALLENGES:
Powder Flow Compaction Dissolution


ADDITIONAL INFO / COMMENTS

Use part of the binder extragranularly. Use VIVASOL® extragranularly and other disintegrants in the granules.

IDEAL PROCESS:
Direct Compression
CHALLENGES:
No Particular Challenge

RECOMMENDED EXCIPIENTS
Binder:
No Binder Needed
Disintegrant:
Lubricant:
OR

ADDITIONAL INFO / COMMENTS

When using PROSOLV® EASYtab SP , add more disintegrant and lubricant, if needed.

IDEAL PROCESS:
Direct Compression
CHALLENGES:
No Particular Challenge

RECOMMENDED EXCIPIENTS
Binder:
No Binder Needed
Filler/Binder:
One of the following
Disintegrant:
One of the following
Lubricant:
OR

ADDITIONAL INFO / COMMENTS

When using PROSOLV® EASYtab SP , add more disintegrant and lubricant, if needed.

IDEAL PROCESS:
Direct Compression
CHALLENGES:
Compaction

RECOMMENDED EXCIPIENTS
Disintegrant:
Lubricant:
IDEAL PROCESS:
Direct Compression
CHALLENGES:
Compaction Dissolution

RECOMMENDED EXCIPIENTS
Disintegrant:
One of the following
Lubricant:

IDEAL PROCESS:
Roller Compaction
CHALLENGES:
Powder Flow


ADDITIONAL INFO / COMMENTS

Alternatively, use a blend of PROSOLV® SMCC 50 LD (70%) and EMCOMPRESS® Anhydrous (30%) in the ribbon.

IDEAL PROCESS:
Roller Compaction
CHALLENGES:
Powder Flow Dissolution


ADDITIONAL INFO / COMMENTS

Alternatively, use a blend of PROSOLV® SMCC 50 LD (70%)and EMCOMPRESS® Anhydrous (30%) in the ribbon.

IDEAL PROCESS:
Roller Compaction
CHALLENGES:
Powder Flow Compaction

RECOMMENDED EXCIPIENTS
Disintegrant:
Lubricant:

ADDITIONAL INFO / COMMENTS

Alternatively, use a blend of PROSOLV® SMCC 50 LD (70%) and EMCOMPRESS® Anhydrous (30%) in the ribbon, use binder intra- and extragranularly.

IDEAL PROCESS:
Roller Compaction
CHALLENGES:
Powder Flow Compaction Dissolution


ADDITIONAL INFO / COMMENTS

Alternatively, use a blend of PROSOLV® SMCC 50 LD (70%) and EMCOMPRESS® Anhydrous (30%) in the ribbon, use binder intra- and extragranularly.

IDEAL PROCESS:
Direct Compression
CHALLENGES:
Content Uniformity

RECOMMENDED EXCIPIENTS
Binder:
No Binder Needed
Filler/Binder:
Disintegrant:
One of the following
Lubricant:
OR

ADDITIONAL INFO / COMMENTS

Geometric blending to ensure Content Uniformity. When using PROSOLV® EASYtab SP , geometric blending to ensure Content Uniformity.

IDEAL PROCESS:
Direct Compression
CHALLENGES:
Content Uniformity

RECOMMENDED EXCIPIENTS
Binder:
No Binder Needed
Filler/Binder:
Disintegrant:
One of the following
Lubricant:
OR

ADDITIONAL INFO / COMMENTS

Geometric blending to ensure Content Uniformity. When using PROSOLV® EASYtab SP, geometric blending to ensure Content Uniformity.

Use this guide to help simplify the tablet formulation process by selecting the four API Criteria above.
HOW TO USE THE TABLET FORMULATION GUIDE

  1. Click on each of the above API Criteria in the menu.
  2. Select a specification from the drop-down options for each API Criteria.
  3. When you have made selections for all four API Criteria, recommended excipients and other resources will be displayed to assist with your formulation.
  4. To adjust your specifications, click on the criteria you would like to change and make a different selection. Or if you want to start again, hit the reset button.
ABOUT THE JRS PHARMA TABLET FORMULATION GUIDE

When developing a formulation for an immediate release tablet, critical attributes of the active ingredient, including concentration, compactability, flowability and solubility typically guide excipient selection. They also determine the type of manufacturing process that will be used in commercial production. This tablet formulation guide was developed to help simplify and optimize the excipient and manufacturing process selection using those four active ingredient attributes.