Tablet Formulation Guide
Select all four API Criteria to find the best Process, Excipients, Comments and JRS Formulation Handbook Reference
PROCESS |
Challenges: |
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Recommended Method: |
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JRS FORMULATION HANDBOOK REFERENCE Click on link to visit page |
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0 |
PROCESS |
Challenges: |
Powder Flow |
Recommended Method: |
Wet Granulation (Fluid Bed) |
| Compaction | | | |
| Dissolution | | | Case Ztest |
EXCIPIENT |
Binder: |
VIVAPHARM® PVP K 30 |
or |
VIVAPHARM® PVP K 30 |
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Filler/Binder: |
One of the following: |
or |
PROSOLV® EASYtab SP |
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VIVAPUR MCC® (Any DC grade) |
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EMOCEL® 90 MCC |
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PROSOLV® 90 SMCC |
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EMDEX® Dextrates |
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Disintegrant: |
One of the following: |
and |
VIVASOL® |
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VIVASTAR® SSG |
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EXPLOTAB® SSG |
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VIVAPHARM® PVPP |
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Lubricant: |
PRUV® SFF or Mg stearate |
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COMMENTS |
Alternatively use a blend of PROSOLV® SMCC 50 LD (70%) and EMCOMPRESS® Anhydrous (30%) in the ribbon, use binder intra- and extragranularly |
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Alternatively use a blend of PROSOLV® SMCC 50 LD (70%) and EMCOMPRESS® Anhydrous (30%) in the ribbon, use binder intra- and extragranularly |
JRS FORMULATION HANDBOOK REFERENCE Click on link to visit page |
Acetylsalicylic Acid 4282-001 |
Link line 1B |
Link line 1C |
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Link line 2A |
Link line 2B |
Link line 2C |
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Link line 3A |
Link line 3B |
Link line 3C |
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PROCESS |
Challenges: |
No Particular Challenge |
Recommended Method: |
Direct Compression |
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EXCIPIENT |
Binder: |
no binder |
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Filler/Binder: |
One of the following: |
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VIVAPUR MCC® (Any DC grade) |
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EMOCEL® 90 MCC |
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PROSOLV® SMCC |
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EMDEX® Dextrates |
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or PROSOLV® EASYtab SP |
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Disintegrant: |
VIVASOL® CCS |
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Lubricant: |
PRUV® SFF or Mg stearate |
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COMMENTS |
Select filler/binder grade according to API's particle size distribution |
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If using PROSOLV® EASYtab SP, add more disintegrant and lubricant, if need should be |
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PROCESS |
Challenges: |
Dissolution |
Recommended Method: |
Direct Compression |
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EXCIPIENT |
Binder: |
no binder |
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Filler/Binder: |
One of the following: |
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|
VIVAPUR MCC® (Any DC grade) |
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EMOCEL® 90 MCC |
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PROSOLV® SMCC |
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or PROSOLV® EASYtab SP |
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Disintegrant: |
One of the following: |
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VIVASTAR® SSG |
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EXPLOTAB® SSG |
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VIVAPHARM® PVPP |
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COMMENTS |
Select filler/binder grade according to API's particle size distribution |
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If using PROSOLV® EASYtab SP, add more disintegrant and lubricant, if need should be |
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PROCESS |
Challenges: |
Compaction |
Recommended Method: |
Wet Granulation (Fluid Bed) |
| | | | |
| | | | |
EXCIPIENT |
Binder: |
VIVAPHARM® PVP K 30
or
VIVAPHARM® HPMC E 6 |
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Filler/Binder: |
PROSOLV® SMCC 50 (intragranular)
or
PROSOLV® SMCC 90 (extragranular) |
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Disintegrant: |
VIVASOL® CCS |
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Lubricant: |
PRUV® SFF or Mg stearate |
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JRS FORMULATION HANDBOOK REFERENCE Click on link to visit page |
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3 |
PROCESS |
Challenges: |
Compaction |
Recommended Method: |
Wet Granulation (Fluid Bed) |
| Dissolution | | | |
| | | | |
EXCIPIENT |
Binder: |
VIVAPHARM® PVP K 30
or
VIVAPHARM® HPMC E 6 |
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|
Filler/Binder: |
PROSOLV® SMCC 50 (intragranular)
or
PROSOLV® SMCC 90 (extragranular) |
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Disintegrant: |
VIVASOL® CCS and one of the following: |
VIVASTAR® SSG |
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EXPLOTAB® SSG |
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VIVAPHARM® PVPP |
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COMMENTS |
Use VIVASOL® extragranularly and other disintegrants in the granules
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JRS FORMULATION HANDBOOK REFERENCE Click on link to visit page |
Paracetamol 4282-060 (DC Formulation with PROSOLV® EASYtab SP) |
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4 |
PROCESS |
Challenges: |
Powder Flow |
Recommended Method: |
Roller Compaction |
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EXCIPIENT |
Binder: |
VIVAPHARM® PVP/VA 64 |
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Filler/Binder: |
Blend of |
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VIVAPUR® 101 MCC (60%) |
and |
EMCOMPRESS® DCP (40%) |
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Disintegrant: |
VIVASOL® CCS |
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Lubricant: |
PRUV® SFF |
or |
Mg stearate |
COMMENTS |
Use part of the binder extragranularly |
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|
JRS FORMULATION HANDBOOK REFERENCE Click on link to visit page |
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5 |
PROCESS |
Challenges: |
Powder Flow |
Recommended Method: |
Roller Compaction |
| Dissolution | | | |
| | | | |
EXCIPIENT |
Binder: |
VIVAPHARM® PVP/VA 64 |
|
|
|
Filler/Binder: |
Blend of |
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|
VIVAPUR® 101 MCC (60%) |
and |
EMCOMPRESS® DCP (40%) |
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Disintegrant: |
VIVASOL® CCS and one of the following: |
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|
VIVASTAR® SSG |
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|
|
EXPLOTAB® SSG |
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|
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|
VIVAPHARM® PVPP |
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COMMENTS |
Use part of the binder extragranularly. Use VIVASOL® extragranularly and other disintegrants in the granules |
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PROCESS |
Challenges: |
Powder Flow |
Recommended Method: |
Wet Granulation (High Shear) |
| Compaction | | | |
| | | | |
EXCIPIENT |
Binder: |
VIVAPHARM® PVP K 30 |
or |
VIVAPHARM® HPMC E 6 |
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Filler/Binder: |
Intragranular: Blend of |
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PROSOLV® SMCC 50 (70%) |
and |
EMCOMPRESS® Anhydrous (30%) |
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Extragranular: |
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PROSOLV® SMCC HD 90 |
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Disintegrant: |
VIVASOL® CCS |
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Lubricant: |
PRUV® SFF |
or |
Mg stearate |
JRS FORMULATION HANDBOOK REFERENCE Click on link to visit page |
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7 |
PROCESS |
Challenges: |
Powder Flow |
Recommended Method: |
Wet Granulation (High Shear) |
| Compaction | | | |
| Dissolution | | | |
EXCIPIENT |
Binder: |
VIVAPHARM® PVP K 30 |
or |
VIVAPHARM® HPMC E 6 |
|
Filler/Binder: |
Intragranular: Blend of |
|
|
|
|
PROSOLV® SMCC 50 (70%) |
and |
EMCOMPRESS® Anhydrous (30%) |
|
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Extragranular: |
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PROSOLV® SMCC HD 90 |
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Disintegrant: |
VIVASOL® CCS and one of the following: |
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|
|
VIVASTAR® SSG |
|
|
|
|
EXPLOTAB® SSG |
|
|
|
|
VIVAPHARM® PVPP |
|
|
COMMENTS |
Use VIVASOL® extragranularly and other disintegrants in the granules |
|
|
|
JRS FORMULATION HANDBOOK REFERENCE Click on link to visit page |
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|
|
|
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8 |
PROCESS |
Challenges: |
No Particular Challenge |
Recommended Method: |
Direct Compression |
| | | | |
| | | | |
EXCIPIENT |
Binder: |
no binder |
|
|
|
Filler/Binder: |
One of the following: |
|
|
|
|
VIVAPUR MCC® (Any DC grade) |
|
|
|
|
EMOCEL® 90 MCC |
|
|
|
|
PROSOLV® SMCC |
|
|
|
|
EMDEX® Dextrates |
|
or PROSOLV® EASYtab SP |
|
Disintegrant: |
VIVASOL® CCS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lubricant: |
PRUV® SFF or Mg stearate |
|
|
COMMENTS |
|
|
If using PROSOLV® EASYtab SP, add more disintegrant and lubricant, if need should be |
|
JRS FORMULATION HANDBOOK REFERENCE Click on link to visit page |
|
|
|
|
|
|
|
|
|
|
|
|
|
9 |
PROCESS |
Challenges: |
Dissolution |
Recommended Method: |
Direct Compression |
| | | | |
| | | | |
EXCIPIENT |
Binder: |
no binder |
|
|
|
Filler/Binder: |
One of the following: |
|
|
|
|
VIVAPUR MCC® (Any DC grade) |
|
|
|
|
EMOCEL® 90 MCC |
|
|
|
|
PROSOLV® SMCC |
|
|
|
|
|
|
or PROSOLV® EASYtab SP |
|
Disintegrant: |
One of the following: |
|
|
|
|
VIVASTAR® SSG |
|
|
|
|
EXPLOTAB® SSG |
|
|
|
|
VIVAPHARM® PVPP |
|
|
COMMENTS |
|
|
If using PROSOLV® EASYtab SP, add more disintegrant and lubricant, if need should be |
|
PROCESS |
Challenges: |
Compaction |
Recommended Method: |
Direct Compression |
| | | | |
| | | | |
EXCIPIENT |
Binder: |
VIVAPHARM® PVP/VA 64 |
|
|
|
Filler/Binder: |
PROSOLV® SMCC 50 |
or |
PROSOLV® SMCC 50 LD |
|
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Disintegrant: |
VIVASOL® CCS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lubricant: |
PRUV® SFF |
or |
Mg stearate |
PROCESS |
Challenges: |
Compaction |
Recommended Method: |
Direct Compression |
| Dissolution | | | |
| | | | |
EXCIPIENT |
Binder: |
VIVAPHARM® PVP/VA 64 |
|
|
|
Filler/Binder: |
PROSOLV® SMCC 50 |
or |
PROSOLV® SMCC 50 LD |
|
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|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
Disintegrant: |
One of the following: |
|
|
|
|
VIVASTAR® SSG |
|
|
|
|
EXPLOTAB® SSG |
|
|
|
|
VIVAPHARM® PVPP |
|
|
PROCESS |
Challenges: |
Powder Flow |
Recommended Method: |
Roller Compaction |
| | | | |
| | | | |
EXCIPIENT |
Binder: |
VIVAPHARM® PVP/VA 64 |
|
|
|
Filler/Binder: |
PROSOLV® SMCC 50 (ribbon) |
and |
PROSOLV® SMCC 90 (external phase) |
|
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|
|
|
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|
|
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Disintegrant: |
VIVASOL® CCS and one of the following: |
|
|
|
|
VIVASTAR® SSG |
|
|
|
|
EXPLOTAB® SSG |
|
|
|
|
VIVAPHARM® PVPP |
|
|
|
Lubricant: |
PRUV® SFF |
or |
Mg stearate |
COMMENTS |
Alternatively use a blend of PROSOLV® SMCC 50 LD (70%) and EMCOMPRESS® Anhydrous (30%) in the ribbon |
|
|
|
JRS FORMULATION HANDBOOK REFERENCE Click on link to visit page |
|
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|
|
|
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|
|
|
|
|
13 |
PROCESS |
Challenges: |
Powder Flow |
Recommended Method: |
Roller Compaction |
| Dissolution | | | |
| | | | |
EXCIPIENT |
Binder: |
VIVAPHARM® PVP/VA 64 |
|
|
|
Filler/Binder: |
PROSOLV® SMCC 50 (ribbon) |
and |
PROSOLV® SMCC 90 (external phase) |
|
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|
|
|
|
|
|
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|
|
|
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|
|
|
|
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|
|
|
Disintegrant: |
VIVASOL® CCS and one of the following: |
|
|
|
|
VIVASTAR® SSG |
|
|
|
|
EXPLOTAB® SSG |
|
|
|
|
VIVAPHARM® PVPP |
|
|
COMMENTS |
Alternatively use a blend of PROSOLV® SMCC 50 LD (70%) and EMCOMPRESS® Anhydrous (30%) in the ribbon |
|
|
|
PROCESS |
Challenges: |
Powder Flow |
Recommended Method: |
Roller Compaction |
| Compaction | | | |
| | | | |
EXCIPIENT |
Binder: |
VIVAPHARM® PVP/VA 64 |
|
|
|
Filler/Binder: |
PROSOLV® SMCC 50 (ribbon) |
and |
PROSOLV® SMCC 90 (external phase) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Disintegrant: |
VIVASOL® CCS and one of the following: |
|
|
|
|
VIVASTAR® SSG |
|
|
|
|
EXPLOTAB® SSG |
|
|
|
|
VIVAPHARM® PVPP |
|
|
|
Lubricant: |
PRUV® SFF |
or |
Mg stearate |
COMMENTS |
Alternatively use a blend of PROSOLV® SMCC 50 LD (70%) and EMCOMPRESS® Anhydrous (30%) in the ribbon, use binder intra- and extragranularly |
|
|
|
PROCESS |
Challenges: |
Powder Flow |
Recommended Method: |
Roller Compaction |
| Compaction | | | |
| Dissolution | | | |
EXCIPIENT |
Binder: |
VIVAPHARM® PVP/VA 64 |
|
|
|
Filler/Binder: |
PROSOLV® SMCC 50 (ribbon) |
and |
PROSOLV® SMCC 90 (external phase) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Disintegrant: |
VIVASOL® CCS and one of the following: |
|
|
|
|
VIVASTAR® SSG |
|
|
|
|
EXPLOTAB® SSG |
|
|
|
|
VIVAPHARM® PVPP |
|
|
COMMENTS |
Alternatively use a blend of PROSOLV® SMCC 50 LD (70%) and EMCOMPRESS® Anhydrous (30%) in the ribbon, use binder intra- and extragranularly |
|
|
|
PROCESS |
Challenges: |
Content Uniformity |
Recommended Method: |
Direct Compression |
| | | | |
| | | | |
EXCIPIENT |
Binder: |
no binder |
|
|
|
Filler/Binder: |
PROSOLV® SMCC 90 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
or PROSOLV® EASYtab SP |
|
Disintegrant: |
One of the following: |
|
|
|
|
VIVASTAR® SSG |
|
|
|
|
EXPLOTAB® SSG |
|
|
|
|
VIVAPHARM® PVPP |
|
|
|
Lubricant: |
PRUV® SFF or Mg stearate |
|
|
COMMENTS |
Geometric blending to ensure CU |
|
If using PROSOLV® EASYtab SP, geometric blending to ensure CU |
|
JRS FORMULATION HANDBOOK REFERENCE Click on link to visit page |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17 |
PROCESS |
Challenges: |
Content Uniformity |
Recommended Method: |
Direct Compression |
| | | | |
| | | | |
EXCIPIENT |
Binder: |
no binder |
|
|
|
Filler/Binder: |
PROSOLV® SMCC 90 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
or PROSOLV® EASYtab SP |
|
Disintegrant: |
One of the following: |
|
|
|
|
VIVASTAR® SSG |
|
|
|
|
EXPLOTAB® SSG |
|
|
|
|
VIVAPHARM® PVPP |
|
|
COMMENTS |
Geometric blending to ensure CU |
|
If using PROSOLV® EASYtab SP, geometric blending to ensure CU |
|
Case 30 |
CT needs to debug this |
|
|
|
| | | | |
| | | | |
PROCESS |
Challenges: |
Case99 |
Recommended Method: |
Wet Granulation (Fluid Bed) |
| Compaction | | | |
| Dissolution | | | |