APR Sept/Oct 2023 - 102

SPONSORED CONTENT
VITAMIN C -
Tableting with LUBRITAB® RBW Lubricant
Aim of the study
Vitamin C (ascorbic acid) is a popular supplement
available over the counter in dosage forms such as
tablets, capsules, sprinkles and gummies. From a
formulator's perspective, it can be challenging since it
is poorly compressible and is very sensitive to moisture.
Because of this, it requires effective lubrication to
facilitate ejection, but with minimal impact on tablet
hardness.
This issue is common among supplements and is the
" double-edged sword " of tablet lubrication. This study
compared the lubricant functionality of LUBRITAB®
RBW (rice bran wax) at several levels with a commonly
used lubricant, stearic acid.
Vitamin C
From the therapeutic perspective, Vitamin C is a
nutrient necessary for survival. It plays a role in tissue
development and repair. It also supports the efficient
function of the immune system, wound healing,
maintenance of bone and connective tissue health,
collagen formation and absorption of iron. Claimed
to be one of the safest nutrients, it is touted to be an
effective treatment in resistance to and treatment of
common cold viruses.
Formulation
The tablet formulation consisted of Vitamin C
(ascorbic acid, USP), PROSOLV® SMCC 90 as binder,
VIVASOL® croscarmellose sodium as disintegrant, and
LUBRITAB® RBW as lubricant. One additional
formulation included stearic acid (USP/NF) at 2.0% in
place of LUBRITAB® RBW, for comparison.
Formulation
Vitamin C
PROSOLV® SMCC 90
VIVASOL®
Croscarmellose Sodium
LUBRITAB® RBW
Total
Excipients
LUBRITAB® RBW is an all-natural, plant-based, clean
label lubricant that is desirable for nutraceutical
applications. PROSOLV® SMCC 90 was chosen for its
excellent flow and compactibility characteristics, while
VIVASOL® CCS is an effective wicking-type disintegrant
that will pull water into the tablets to facilitate tablet
disintegration and dissolution of the Vitamin C.
Procedure
Blending
Vitamin C was added to a low shear mixing vessel along
with PROSOLV® SMCC 90, VIVASOL® CCS, and 20-mesh
screened LUBRITAB® RBW. After blending for five
minutes, the blends were immediately used for direct
compression tableting.
Equipment
Low Shear Mixer
Tablet Press
Hardness Tester
Glen Mills Turbula
Piccola Rotary Instrumented Tablet Press
Sotax Model HT10 Hardness Tester
Tablet Characteristics
Tablet Weight
Tablet Shape
Tablet Height
mg/Tablet
500.0
430.0-457.5
40.0
2.5-30.0
1000.0
Contribution (%)
50.00
43.00-45.75
4.0
0.25-3.0
100.0
1000.0 mg
0.325 " x 0.675 " modified oval
6.4 - 7.2 mm
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APR Sept/Oct 2023

Table of Contents for the Digital Edition of APR Sept/Oct 2023

INSIDER INSIGHT - From Guidelines to Standards: Why Comprehensive AI Regulation is Essential to Spurring Innovation
BIOPHARMACEUTICAL - Aseptic Process Simulation: Cell and Gene Therapy Manufacture
FORMULATION & DEVELOPMENT - Challenges of Analytical Validation for ATMPs
QC Corner - The Intricacies of Testing for Mycoplasmas in Cell Culture Systems
MICROBIOLOGY - Standardized, Scalable And Efficient: Producing Recombinant Factor C to Quality Standards
FORMULATION AND DEVELOPMENT - R Code to Estimate Probability of Passing USP Dissolution Test
FORMULATION AND DEVELOPMENT - Cloud Computing for Drug Discovery: The Time is Now
CGT CIRCUIT - Navigating the Complex Testing Strategies for Viral Vector-based Gene Therapies
MANUFACTURING - Simplifying Finished Product Manufacturer Site Transfer Variations
FORMULATION AND DEVELOPMENT - Advancing Regulatory Compliance with Natural Language Processing
DRUG DELIVERY - Finding a Greater Vantage Point for Creating Green Therapies
WHITEPAPER - Microbial Testing for the Pharmaceutical Industry
Facility Tour - Eurofins BioPharma Product Testing
ROUNDTABLE - Drug Delivery
MANUFACTURING - Accelerating Biologics R&D with Unified Software and Data Flows
An Interview with Jason Downing, Senior Product Manager, TriLink BioTechnologies®
FORMULATION AND DEVELOPMENT - The Role of Data in the Pharmaceutical Lifecycle
BIOPHARMACEUTICAL - Uniting Quality Expectations on Reinvigorated Biopharma Campuses
WHITEPAPER - VITAMIN C – Tableting with LUBRITAB® RBW Lubricant
WHITEPAPER - Leveraging Analytical Technology Process for CMC
BIOPHARMACEUTICAL - Maximizing the Commercialization Potential of Cell and Gene Therapies
MICROBIOLOGY - Comments on Aseptic Process Simulation (APS) in the New EU GMP Annex 1
VENDOR VIEWPOINT - Continuous & Intervention-Free Microbial Monitoring
APR Sept/Oct 2023 - Cover1
APR Sept/Oct 2023 - Cover2
APR Sept/Oct 2023 - 1
APR Sept/Oct 2023 - 2
APR Sept/Oct 2023 - 3
APR Sept/Oct 2023 - 4
APR Sept/Oct 2023 - 5
APR Sept/Oct 2023 - 6
APR Sept/Oct 2023 - 7
APR Sept/Oct 2023 - 8
APR Sept/Oct 2023 - 9
APR Sept/Oct 2023 - 10
APR Sept/Oct 2023 - 11
APR Sept/Oct 2023 - 12
APR Sept/Oct 2023 - 13
APR Sept/Oct 2023 - 14
APR Sept/Oct 2023 - 15
APR Sept/Oct 2023 - 16
APR Sept/Oct 2023 - 17
APR Sept/Oct 2023 - 18
APR Sept/Oct 2023 - 19
APR Sept/Oct 2023 - 20
APR Sept/Oct 2023 - 21
APR Sept/Oct 2023 - 22
APR Sept/Oct 2023 - 23
APR Sept/Oct 2023 - 24
APR Sept/Oct 2023 - 25
APR Sept/Oct 2023 - 26
APR Sept/Oct 2023 - 27
APR Sept/Oct 2023 - 28
APR Sept/Oct 2023 - 29
APR Sept/Oct 2023 - 30
APR Sept/Oct 2023 - INSIDER INSIGHT - From Guidelines to Standards: Why Comprehensive AI Regulation is Essential to Spurring Innovation
APR Sept/Oct 2023 - 32
APR Sept/Oct 2023 - 33
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Aseptic Process Simulation: Cell and Gene Therapy Manufacture
APR Sept/Oct 2023 - 35
APR Sept/Oct 2023 - 36
APR Sept/Oct 2023 - 37
APR Sept/Oct 2023 - 38
APR Sept/Oct 2023 - 39
APR Sept/Oct 2023 - 40
APR Sept/Oct 2023 - 41
APR Sept/Oct 2023 - 42
APR Sept/Oct 2023 - 43
APR Sept/Oct 2023 - FORMULATION & DEVELOPMENT - Challenges of Analytical Validation for ATMPs
APR Sept/Oct 2023 - 45
APR Sept/Oct 2023 - 46
APR Sept/Oct 2023 - 47
APR Sept/Oct 2023 - 48
APR Sept/Oct 2023 - 49
APR Sept/Oct 2023 - QC Corner - The Intricacies of Testing for Mycoplasmas in Cell Culture Systems
APR Sept/Oct 2023 - 51
APR Sept/Oct 2023 - MICROBIOLOGY - Standardized, Scalable And Efficient: Producing Recombinant Factor C to Quality Standards
APR Sept/Oct 2023 - 53
APR Sept/Oct 2023 - 54
APR Sept/Oct 2023 - 55
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - R Code to Estimate Probability of Passing USP Dissolution Test
APR Sept/Oct 2023 - 57
APR Sept/Oct 2023 - 58
APR Sept/Oct 2023 - 59
APR Sept/Oct 2023 - 60
APR Sept/Oct 2023 - 61
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - Cloud Computing for Drug Discovery: The Time is Now
APR Sept/Oct 2023 - 63
APR Sept/Oct 2023 - 64
APR Sept/Oct 2023 - 65
APR Sept/Oct 2023 - 66
APR Sept/Oct 2023 - 67
APR Sept/Oct 2023 - CGT CIRCUIT - Navigating the Complex Testing Strategies for Viral Vector-based Gene Therapies
APR Sept/Oct 2023 - 69
APR Sept/Oct 2023 - MANUFACTURING - Simplifying Finished Product Manufacturer Site Transfer Variations
APR Sept/Oct 2023 - 71
APR Sept/Oct 2023 - 72
APR Sept/Oct 2023 - 73
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - Advancing Regulatory Compliance with Natural Language Processing
APR Sept/Oct 2023 - 75
APR Sept/Oct 2023 - 76
APR Sept/Oct 2023 - 77
APR Sept/Oct 2023 - DRUG DELIVERY - Finding a Greater Vantage Point for Creating Green Therapies
APR Sept/Oct 2023 - 79
APR Sept/Oct 2023 - 80
APR Sept/Oct 2023 - 81
APR Sept/Oct 2023 - WHITEPAPER - Microbial Testing for the Pharmaceutical Industry
APR Sept/Oct 2023 - 83
APR Sept/Oct 2023 - 84
APR Sept/Oct 2023 - 85
APR Sept/Oct 2023 - Facility Tour - Eurofins BioPharma Product Testing
APR Sept/Oct 2023 - 87
APR Sept/Oct 2023 - 88
APR Sept/Oct 2023 - ROUNDTABLE - Drug Delivery
APR Sept/Oct 2023 - 90
APR Sept/Oct 2023 - 91
APR Sept/Oct 2023 - MANUFACTURING - Accelerating Biologics R&D with Unified Software and Data Flows
APR Sept/Oct 2023 - 93
APR Sept/Oct 2023 - An Interview with Jason Downing, Senior Product Manager, TriLink BioTechnologies®
APR Sept/Oct 2023 - 95
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - The Role of Data in the Pharmaceutical Lifecycle
APR Sept/Oct 2023 - 97
APR Sept/Oct 2023 - 98
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Uniting Quality Expectations on Reinvigorated Biopharma Campuses
APR Sept/Oct 2023 - 100
APR Sept/Oct 2023 - 101
APR Sept/Oct 2023 - WHITEPAPER - VITAMIN C – Tableting with LUBRITAB® RBW Lubricant
APR Sept/Oct 2023 - 103
APR Sept/Oct 2023 - WHITEPAPER - Leveraging Analytical Technology Process for CMC
APR Sept/Oct 2023 - 105
APR Sept/Oct 2023 - 106
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Maximizing the Commercialization Potential of Cell and Gene Therapies
APR Sept/Oct 2023 - 108
APR Sept/Oct 2023 - 109
APR Sept/Oct 2023 - MICROBIOLOGY - Comments on Aseptic Process Simulation (APS) in the New EU GMP Annex 1
APR Sept/Oct 2023 - 111
APR Sept/Oct 2023 - 112
APR Sept/Oct 2023 - 113
APR Sept/Oct 2023 - VENDOR VIEWPOINT - Continuous & Intervention-Free Microbial Monitoring
APR Sept/Oct 2023 - 115
APR Sept/Oct 2023 - 116
APR Sept/Oct 2023 - 117
APR Sept/Oct 2023 - 118
APR Sept/Oct 2023 - 119
APR Sept/Oct 2023 - 120
APR Sept/Oct 2023 - Cover3
APR Sept/Oct 2023 - Cover4
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