Tablet Formulation Guide
Where does your API fall with respect to the four categories?  
   
API CRITERIA Dose Flowability Compactibility Solubility
 
 
 
PROCESS Challenges:   Recommended Method:  
     
     
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
     
    
EXCIPIENT Binder: No Binder Needed
 
  Filler/Binder: One of the following:
 
    VIVAPUR MCC® (Any DC grade)
 
    EMCOCEL® 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
When using PROSOLV® EASYtab SP, add more disintegrant and lubricant, if needed  
JRS FORMULATION
HANDBOOK REFERENCE
Click on link to visit page		 Ranitidine HCl 4282-020      
         
        1
PROCESS Challenges: Dissolution Recommended Method: Direct Compression
     
    
EXCIPIENT Binder: No Binder Needed
 
  Filler/Binder: One of the following:
 
    VIVAPUR MCC® (Any DC grade)
 
    EMCOCEL® 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
When using PROSOLV® EASYtab SP, add more disintegrant and lubricant, if needed  
JRS FORMULATION
HANDBOOK REFERENCE
Click on link to visit page		 Acetylsalicylic Acid 4282-001 Clotrimazole 4282-053    
Acetylsalicylic Acid 4282-023 Mebendazole 4282-067      
Cefalexin 4282-040       2
PROCESS Challenges: Compaction Recommended Method: Wet Granulation (Fluid Bed)
     
    
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		        
         
        3
PROCESS Challenges: Compaction Recommended Method: Wet Granulation (Fluid Bed)
 Dissolution   
    
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)      
         
        4
PROCESS Challenges: Powder Flow Recommended Method: Roller Compaction
     
    
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		        
         
        5
PROCESS Challenges: Powder Flow Recommended Method: Roller Compaction
 Dissolution   
    
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      
         
        6
PROCESS Challenges: Powder Flow Recommended Method: Wet Granulation (High Shear)
 Compaction   
    
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		        
         
        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%)
    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		        
         
        8
PROCESS Challenges: No Particular Challenge Recommended Method: Direct Compression
     
    
EXCIPIENT Binder: No Binder Needed
 
  Filler/Binder: One of the following:
 
    VIVAPUR MCC® (Any DC grade)
 
    EMCOCEL® 90 MCC
 
    PROSOLV® SMCC
 
    EMDEX® Dextrates
  or   PROSOLV® EASYtab SP
  Disintegrant: VIVASOL® CCS
 
     
 
     
 
  Lubricant: PRUV® SFF  or  Mg Stearate
 
COMMENTS  
When using PROSOLV® EASYtab SP, add more disintegrant and lubricant, if needed  
JRS FORMULATION
HANDBOOK REFERENCE
Click on link to visit page		        
         
        9
PROCESS Challenges: Dissolution Recommended Method: Direct Compression
     
    
EXCIPIENT Binder: No Binder Needed
 
  Filler/Binder: One of the following:
 
    VIVAPUR MCC® (Any DC grade)
 
    EMCOCEL® 90 MCC
 
    PROSOLV® SMCC
  or   PROSOLV® EASYtab SP
  Disintegrant: One of the following:
 
    VIVASTAR® SSG
 
    EXPLOTAB® SSG
 
    VIVAPHARM® PVPP
 
  Lubricant: PRUV® SFF
 
COMMENTS  
When using PROSOLV® EASYtab SP, add more disintegrant and lubricant, if needed  
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
    10
PROCESS Challenges: Compaction Recommended Method: Direct Compression
     
    
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)       11
PROCESS Challenges: Compaction Recommended Method: Direct Compression
 Dissolution   
    
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        
          12
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)
          
           
           
         
  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		        
         
        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)
          
           
           
         
  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)       14
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      
JRS FORMULATION
HANDBOOK REFERENCE
Click on link to visit page		 Silymarin 4282-036      
         
        15
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    
  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)     16
PROCESS Challenges: Content Uniformity Recommended Method: Direct Compression
     
    
EXCIPIENT Binder: No Binder Needed
 
  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 Content Uniformity
When using PROSOLV® EASYtab SP, geometric blending to ensure Content Uniformity  
JRS FORMULATION
HANDBOOK REFERENCE
Click on link to visit page		        
         
        17
PROCESS Challenges: Content Uniformity Recommended Method: Direct Compression
     
    
EXCIPIENT Binder: No Binder Needed
 
  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 Content Uniformity
When using PROSOLV® EASYtab SP, geometric blending to ensure Content Uniformity  
JRS FORMULATION
HANDBOOK REFERENCE
Click on link to visit page		 Risperidone 4282-049
Amlodipine 4282-050    
Chromium Picolinate 4282-005
Piroxicam 4282-061    
Enalapril Maleate 4282-007
    18
Case 30 CT needs to debug this      
     
     
PROCESS Challenges: Case99 Recommended Method: Wet Granulation (Fluid Bed)
 Compaction   
 Dissolution