In vitro studies are critical to drug and wellness product development due to their ability to provide a basis for clinical in vivo studies for predicting best delivery model to take Go/No-Go decision. Our solution on in vitro analyses can provide proof of concept on delivery dosage form in the early stages or reverse pharmacology development of the active process, when the selectivity and possible interactions of the candidate drug towards the desired therapeutic target are established.

1. Think Innovative
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Clinical Biowaiver Program

2.  In vitro studies are critical to drug and wellness product development due to their ability to
provide a basis for clinical in vivo studies for predicting best delivery model to take Go/No-Go
decision. Our solution on in vitro analyses can provide proof of concept on delivery dosage form
in the early stages or reverse pharmacology development of the active process, when the
selectivity and possible interactions of the candidate drug towards the desired therapeutic target
are established
 Our team can provide solution map on case to case basis for your specific requirement
Proof of concept studies for development
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3. Therapeutic area of invitro Program
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4.  In vitro Models are important as alternatives to animal &
human testing and are key to efficacy & safety assessment
activities
 In vitro evaluation provides a complete suite of drug
release assays and bio waiver studies for a variety of
dosage forms ranging from simple tablets to transdermal
formulations
 As drug products continue to increase in complexity, there
has been a growing initiative to enhance evaluation by
introducing the concepts of quality target product profile
(QTPP) and quality by design (QbD)
 By complementing the traditional paradigm of ‘equivalence
by testing’ the current framework encourages the use of
appropriate surrogates to target pharmaceutical
equivalence by design and it is accepted by regulatory also
Bio waiver of In vivo studies
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5. Bio pharmaceutics dissolution with better in viva correlation
The In Vitro Dissolution Absorption System
Combines traditional dissolution testing with a means to determine and quantify interactions
with a bio-relevant membrane. IDAS provides the ability to evaluate absorption, permeation,
accumulation, biomarker regulation, and metabolism, as well as the ability to test a finished
dosage form from a tablet, capsule to suspension. The characterized and validated system
allows for multiple dissolution media and drug products from all BCS classes.
Applications:
Evaluate Formulations- Bioequivalence, Post Approval Changes, 505[b] [2] Formulations,
Evaluate Food Effects ,Evaluate Locally Acting GI Products
Who benefits from IDAS™?
If you are struggling with any of the following:
Independent measured solubility, permeability, and dissolution that rarely has physiologic
relevance poor correlation between in vitro drug product release characteristics and in vivo
performance Limited utility of in vitro data in formulation development optimization.
Franz cells instrument
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6. In Vitro permeation testing (IVPT) studies across biological membranes for formulations that are applied to the skin
or in the eye are vital to guide product development and establish product bioequivalence, combined with QbD-
guided formulation development and robust IVRT methodologies
Ophthalmic
Topical
In vitro permeation testing (IVPT)
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7. IVPT Study Design :
 Optimization of study conditions: analytical, receiver buffer, time-point selection and dose amount
 Establishment of sensitivity and selectivity
 Qualification of the optimized assay parameters
 Validation: Analytical method validation and test system validation including recovery, mass
balance and dose depletion
In vitro permeation testing (IVPT)
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8. Choices for approaches
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9. Nasogastric and gastronomy (NG) tube In vitro studies:
Sr. No Molecule Route Applications
1 Cholestyramine( Light /Regular ) Suspension/Oral Anti-cholesterol (Bile acid sequestrate)
2 Colesevelam Tablet/Suspension Oral Anti-cholesterol (Bile acid sequestrate)
3 Colestipol Granule,Oral Anti-cholesterol (Bile acid sequestrate)
4 Sevelamer Suspension;Oral Renal(Phosphate Binding)
5 Sevelamer Carbonate Tablet/Suspension,Oral Renal(Phosphate Binding)
6 Lanthanum Carbonate Chewable Tablets/Oral Anti-cholesterol (Bile acid sequestrate)
7 Calcium Acetate Chewable Tablets/Oral Renal(Phosphate Binding)
8 Sodium Polysyrene Sulfonate Powder,Oral/rectal Renal(K+Binding)
9 calcium Polystyrene Sulfonate Tablet/Suspension,Oral Renal(K+Binding)
10 Lanthum, Carbonate Suspension/Oral Phosphate equilibrium & Kinetics studies
11 Sucroferric Ox hydroxide Tablet/Suspension,Oral Phosphate equilibrium & Kinetics studies
12 Ferric Citrate Granule,Oral Phosphate equilibrium & Kinetics studies
13 Sucralfate Suspension/Oral Phosphate equilibrium & Kinetics studies
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10. Nasogastric and gastronomy (NG) tube In vitro studies:
Sr. No Molecule Route Applications
1 Lansoprazoloe DR Capsule Delayed Release Capsule/Oral Proton pump inhibitor
2 Esomeprazole Strontium DR Capsule Capsule ,Delayed Release; Oral Proton pump inhibitor
3 Esomeprazole Magnesium DR Capsule Capsule ,Delayed Release Pellets; Oral Proton pump inhibitor
4 Morphine Sulphate Extended Release Capsule; Oral Pain Management
5 Rivaroxaban Tablet; Oral Anticoagulant
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11.  In vitro release of API from topical and transdermal products,
and subsequent permeation through a membrane, can be tested
in a vertical diffusion cell (i.e. Franz diffusion cell)
 In this apparatus, formulation is applied or put in contact with a
membrane that is in contact with a receiving medium
 The receiving medium is sampled as a function of time and API
is quantities to determine a permeation/flux profile
 Membrane materials include synthetic polymer, tissue
constructs
 The choice of membrane is driven by the purpose of the test (i.e.
development vs. quality control) and robustness of the model
 This technique is applicable not only to externally applied
topical formulations, but also to products that deliver via the
vaginal, rectal, buccal, or nasal routes
Topical and transdermal In vitro release testing (IVRT)
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12.  In vitro microbial kill rate study is most appropriate tool to
establish the bactericidal or fungicidal effect of the drug product
as well as to understand the dynamic interaction between
antimicrobial agent and microbial strain
 Estimation of antimicrobial effect is dependent on concentration
and time. Study majorly carried out for antibiotics routinely
administered in ophthalmic category
Microbial In vitro evaluation:
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13. Australia
Columbia
Canada
EU
New Zealand
South Africa
Switzerland
Singapore
Bio waiver Region
Taiwan
US
Brazil
South Korea
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For any queries /discussions, Please contact us:
+91 80 41250324
Business Development Team
info@stabicon.com