Tablet Formulation Guide

Select all four API Criteria to find the best Process, Excipients, Comments and JRS Formulation Handbook Reference

API Criteria
 
 
Process Challenges:   Recommended Method:  
     
    Case 0
Excipient Binder:            
  Filler/Binder:        
          
           
           
         
  Disintegrant:       
          
          
           
  Lubricant:        
Comments          
JRS Formulation
Handbook Reference
Click on link to visit page		        
         
         
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
  Filler/Binder: One of the following: or PROSOLV® EASYtab SP
    VIVAPUR MCC® (Any DC grade)    
    EMOCEL® 90 MCC    
    PROSOLV® 90 SMCC    
    EMDEX® Dextrates    
  Disintegrant: One of the following: and VIVASOL®
    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
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  
Link line 2A Link line 2B Link line 2C    
Link line 3A Link line 3B Link line 3C    
Process Challenges: No particular challenge Recommended Method: Direct Compression
     
    Case 1
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 Select filler/binder grade according to API's particle size distribution
If using PROSOLV® EASYtab SP, add more disintegrant and lubricant, if need should be  
JRS Formulation
Handbook Reference
Click on link to visit page		 Ranitidine HCl 4282-020      
         
         
Process Challenges: Dissolution Recommended Method: Direct Compression
     
    Case 2
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
 
  Lubricant: PRUV® SFF
 
Comments Select filler/binder grade according to API's particle size distribution
If using PROSOLV® EASYtab SP, add more disintegrant and lubricant, if need should be  
JRS Formulation
Handbook Reference
Click on link to visit page		 Acetylsalicylic Acid 4282-001 Cotrimazole 4282-053    
Acetylsalicylic Acid 4282-023 Mebendazole 4282-067      
Cefalexin 4282-040        
Process Challenges: Compaction Recommended Method: Wet granulation (fluid bed)
     
    Case 3
Excipient Binder: VIVAPHARM® PVP K 30 or VIVAPHARM® HPMC E 6
  Filler/Binder: PROSOLV® SMCC 50 (intragranular) or PROSOLV® SMCC 90 (extragranular)
          
           
           
         
  Disintegrant: VIVASOL® CCS     
          
          
           
  Lubricant: PRUV® SFF or Mg stearate
Comments          
JRS Formulation
Handbook Reference
Click on link to visit page		        
         
         
Process Challenges: Compaction Recommended Method: Wet granulation (fluid bed)
 Dissolution   
    Case 4
Excipient Binder: VIVAPHARM® PVP K 30 or VIVAPHARM® HPMC E 6
  Filler/Binder: PROSOLV® SMCC 50 (intragranular) or PROSOLV® SMCC 90 (extragranular)
          
           
           
         
  Disintegrant: VIVASOL® CCS and one of the following:     
    VIVASTAR® SSG    
    EXPLOTAB® SSG    
    VIVAPHARM® PVPP    
  Lubricant: PRUV® SFF    
Comments Use VIVASOL® extragranularly and other disintegrants in the granules      
JRS Formulation
Handbook Reference
Click on link to visit page		 Paracetamol 4282-060      
(DC Formulation with        
PROSOLV® EASYtab SP)        
Process Challenges: Powder flow Recommended Method: Roller compaction
     
    Case 5
Excipient Binder: VIVAPHARM® PVP/VA 64    
  Filler/Binder: Blend of    
    VIVAPUR® 101 MCC (60%) and EMCOMPRESS® DCP (40%)
           
           
         
  Disintegrant: VIVASOL® CCS     
          
          
           
  Lubricant: PRUV® SFF or Mg stearate
Comments Use part of the binder extragranularly      
JRS Formulation
Handbook Reference
Click on link to visit page		        
         
         
Process Challenges: Powder flow Recommended Method: Roller compaction
 Dissolution   
    Case 6
Excipient Binder: VIVAPHARM® PVP/VA 64    
  Filler/Binder: Blend of    
    VIVAPUR® 101 MCC (60%) and EMCOMPRESS® DCP (40%)
           
           
         
  Disintegrant: VIVASOL® CCS and one of the following:     
    VIVASTAR® SSG    
    EXPLOTAB® SSG    
    VIVAPHARM® PVPP    
  Lubricant: PRUV® SFF    
Comments Use part of the binder extragranularly. Use VIVASOL® extragranularly and other disintegrants in the granules      
JRS Formulation
Handbook Reference
Click on link to visit page		 Ciprofloxacin HCl 4282-006      
         
         
Process Challenges: Powder flow Recommended Method: Wet granulation (high shear)
 Compaction   
    Case 7
Excipient Binder: VIVAPHARM® PVP K 30 or VIVAPHARM® HPMC E 6
  Filler/Binder: Intragranular: Blend of    
    PROSOLV® SMCC 50 (70%) and EMCOMPRESS® Anhydrous (30%)
    Extragranular:    
    PROSOLV® SMCC HD 90    
         
  Disintegrant: VIVASOL® CCS     
         
         
         
  Lubricant: PRUV® SFF or Mg stearate
Comments          
JRS Formulation
Handbook Reference
Click on link to visit page		        
         
         
Process Challenges: Powder flow Recommended Method: Wet granulation (high shear)
 Compaction   
 Dissolution  Case 8
Excipient Binder: VIVAPHARM® PVP K 30 or VIVAPHARM® HPMC E 6
  Filler/Binder: Intragranular: Blend of    
    PROSOLV® SMCC 50 (70%) and EMCOMPRESS® Anhydrous (30%)
    Extragranular:    
    PROSOLV® SMCC HD 90    
         
  Disintegrant: VIVASOL® CCS and one of the following:     
    VIVASTAR® SSG    
    EXPLOTAB® SSG    
    VIVAPHARM® PVPP    
  Lubricant: PRUV® SFF    
Comments Use VIVASOL® extragranularly and other disintegrants in the granules      
JRS Formulation
Handbook Reference
Click on link to visit page		        
         
         
Process Challenges: No particular challenge Recommended Method: Direct Compression
     
    Case 9
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		        
         
         
Process Challenges: Dissolution Recommended Method: Direct Compression
     
    Case 10
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
 
  Lubricant: PRUV® SFF
 
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		 Cimetidine 4282-025
Atenolol 7282-052    
Enalapril + HCT 4282-043
Diclofenac Sodium 4282-055    
Diazepam 4282-022
     
Process Challenges: Compaction Recommended Method: Direct Compression
     
    Case 11
Excipient Binder: VIVAPHARM® PVP /VA 64    
  Filler/Binder: PROSOLV® SMCC 50 or PROSOLV® SMCC 50 LD
          
           
           
         
  Disintegrant: VIVASOL® CCS     
          
          
           
  Lubricant: PRUV® SFF or Mg stearate
Comments          
JRS Formulation
Handbook Reference
Click on link to visit page		 Metoprolol 4282-016 Propranolol HCL 4282-062    
  (DC Formulation with      
  PROSOLV® EASYtab SP)        
Process Challenges: Compaction Recommended Method: Direct Compression
 Dissolution   
    Case 12
Excipient Binder: VIVAPHARM® PVP /VA 64    
  Filler/Binder: PROSOLV® SMCC 50 or PROSOLV® SMCC 50 LD
          
           
           
         
  Disintegrant: One of the following:    
    VIVASTAR® SSG    
    EXPLOTAB® SSG    
    VIVAPHARM® PVPP    
  Lubricant: PRUV® SFF    
Comments          
JRS Formulation
Handbook Reference
Click on link to visit page		 Hydrochlorothiazide 4282-056      
Ginkgo Biloba Extract 4282-009        
           
Process Challenges: Powder flow Recommended Method: Roller compaction
     
    Case 13
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      
JRS Formulation
Handbook Reference
Click on link to visit page		        
         
         
Process Challenges: Powder flow Recommended Method: Roller compaction
 Dissolution   
    Case 14
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    
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		 Simethicone Chewable 4282-021      
Simethicone Chewable 4282-045        
Theophylline 4282-063 (DC Formulation)        
Process Challenges: Powder flow Recommended Method: Roller compaction
 Compaction   
    Case 15
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      
JRS Formulation
Handbook Reference
Click on link to visit page		 Silymarin 4282-036      
         
         
Process Challenges: Powder flow Recommended Method: Roller compaction
 Compaction   
 Dissolution  Case 16
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    
Comments 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		 Ibuprofen 4282-057 (DC Formulations with PROSOLV SMCC)    
Ibuprofen 4282-013 (DC Formulations with PROSOLV SMCC)      
Phloroglucinol 4282-048 (DC Formulations with PROSOLV SMCC)      
Process Challenges: Content uniformity Recommended Method: Direct Compression
     
    Case 17
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		          
         
         
Process Challenges: Content uniformity Recommended Method: Direct Compression
     
    Case 18
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
 
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		 Risperidone 4282-049
Amlodipine 4282-050    
Chromium Picolinate 4282-005
Piroxicam 4282-061    
Enalapril Mleate 4282-007
     
Case 30 CT needs to debug this      
     
     
Process Challenges: Case99 Recommended Method: Wet granulation (fluid bed)
 Compaction   
 Dissolution