Stabicon Business Portfolio

www.stabicon.com
Business Portfolio
Stabicon Life Sciences
Business Development Team
Stabicon FY-2018

Business Portfolio www.stabicon.com
Business Development Email:info@stabicon.com
Stabicon
Life
Sciences
1
Index
Sr.
No
Business Segment Services Portfolio Page No
1 Formulation Development – Dosage 2 -3
2 Brand Extension Form 4-4
3 Biowavier - In-vitro Program 5-7
4 Delivery Enhancement Technology 8-8
5 Formulation Reverse Engineering 9-10
6 Antimicrobial Screening & Dosage Development Program 11-12
7 Laboratory & Stability Program 13-19
8 Turnkey & Training 20-20
9 Referral Lab 21-22

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Sr. No Drug delivery system Type Dosage form
1
Oral Delivery through Digestive
tract(enteral)
Solids
Pill
Tablet
Capsule
Lozenges & Pastille
Buccal & sub lingual Tablets
Osmotic delivery
system (OROS)
Granules, Powder
2 Ophthalmic /Otologic / Nasal
Solid/Semi-
solid/Liquid
Spray
Drops
Ointment
Hydrogel
Insufflation
Mucoadhesive micro disc
(microsphere tablet)
Ointment
3 Urogenital
Solid/Semi-
solid/Liquid
Pessary (vaginal suppository)
Extra-amniotic infusion
Tablets
Intravesical infusion
Ointment
4 Rectal (enteral)
Solid/ Semi-
solid/Liquid
Suppository
Enema
Solution
Hydrogel
Murphy drip
Nutrient enema
Ointment
5 Dermal
Solid/ Semi-
solid/Liquid
Topical gel
Liniment
Paste
Film
1.Formulation Development – Dosage
Form

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Sciences
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Dermal
DMSO drug solution
Hydrogel
Liposomes
Transfer some vesicles
Cream
Lotion
Medicated shampoo
Dusting Powder

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Brand extension or brand stretching is a marketing strategy in which a firm marketing a prod
uct with a well-developed image uses the (same) brand name in a different product category.
Our Offering in more than one product category:
 Extension to related categories.
 Extension to unrelated categories.
We Build strategy of brand extension on following categories:
 Expanding the core promise to the new users.
 Blocking or inhibiting competition.
 Managing a dynamic environment
2.Brand Extension Form

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Section-3a: Invitro Studies for Nonsystematic Drugs
Sr. No Molecule Route Applications
1 Cholestyramine (Light/Regular)
Suspension/ Oral Anti-cholesterol (Bile acid
Sequestrate
2 Colesevelam hydrochloride
Tablet/Suspension: oral Anti-cholesterol (Bile acid
Sequestrate
3 Colestipol hydrochloride
Granule; Oral Anti-cholesterol (Bile acid
Sequestrate
4 Sevelamer hydrochloride Suspension; Oral Renal (Phosphate Binding)
5 Sevelamer Carbonate Tablet/Suspension; Oral Renal (Phosphate Binding)
6 Lanthanum Carbonate
Chewable
Tablets/Oral/Suspension
Renal (Phosphate Binding)
& Kinetics
7 Calcium Acetate Tablets/Oral Renal (Phosphate Binding)
8 Sodium polystyrene sulfonate
Powder; oral/rectal Renal (K+ Binding)
9 Calcium polystyrene sulfonate
Powder; oral/rectal Renal (K+ Binding)
10 Sucroferric Oxyhydroxide
Tablet/Suspension: oral Renal (K+ Binding)
11 Ferric Citrate
Granule; Oral Renal (K+ Binding)
12 Sucralfate
Suspension/ Oral Duodenal ulcer(Bile acid
and protein binding &
pepsin inhibition)
3.Biowavier - In-vitro Program
4.

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Section -3b: Nasogastric and Gastronomy (NG) Tube Invitro Studies
Sr. No Molecules Route Applications
1 Lansoprazole DR Capsule
Delayed Release
Capsule/Oral
Proton pump inhibitor
2
Esomeprazole Strontium DR
Capsule
Capsule, Delayed Release;
Oral
3
Esomeprazole magnesium DR
Capsule
Capsule, Delayed Release
Pellets; Oral
4 Morphine Sulfate
Extended Release Capsule;
Oral
Pain management
5 Rivaroxaban Tablet; Oral Anticoagulant
Section-3c: Topical/Transdermal Invitro Release Testing (IVRT)
Invitro 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.
Section-3d: Microbial Invitro Evaluation:
Invitro microbial kill rate study as per USFDA guidance
Invitro Evaluation of the Antimicrobial properties for various application

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Section-3e: Bio-wavier for Solid Orals:
A Bio-waiver of solid oral means that in vivo bioavailability and/or bioequivalence studies may
be waived (not considered necessary for product approval). Instead of conducting expensive
and time consuming in vivo studies, a dissolution test could be adopted as the surrogate basis
for the decision as to whether the two pharmaceutical products are equivalent.
This kind of study only can be done with specific classification (BCS) class 1 & 3. To understand
BCS (BIOPHARAMCEUTICAL CLASSIFICATION SYSTEM) is a scientific framework for
classifying drug substances based on their aqueous solubility and intestinal permeability
Class I - high permeability, high solubility
Example: Metoprolol- Those compounds are well absorbed and their absorption rate is usually
higher than excretion.
Class III - Low permeability, high solubility
Example: Cimetidine -The absorption is limited by the permeation rate but the drug is solvated
very fast. If the formulation does not change the permeability or gastro-intestinal duration time,
then class I criteria can be applied.
Reference : https://www.fda.gov/downloads/Drugs/Guidances/ucm070246.pdf

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Drug delivery plays a vital role in bringing a drug’s therapeutic value to patients. Our delivery
technologies enhance drug absorption, efficacy, and patient experience. We can improve taste
masking increase the commercial viability of your pharmaceutical products by neutralizing the
strong, bitter tastes of certain oral medical formulations. Our expert can increase
bioavailability of medications within the system by following approaches :-
 To enhance drug solubility
 The surfactant properties of self-emulsifying and self-micro-emulsifying drug delivery
systems (SEDDS and SMEDDS) can be used to improve the dispersion and
solubilisation of drugs in the gastrointestinal tract.
 The digestion of lipid excipients (oils and surfactants) in combination with the drug
product can improve solubilisation and absorption in the gastrointestinal tract.
 To enhance drug absorption, lipid excipients can be used
 To act upon the enterocyte-based transport mechanisms, for example by inhibiting the
P-glycoprotein efflux transporter that controls drug uptake and efflux.
 To facilitate uptake by the lymphatic transport system, thereby eliminating first-pass
metabolism in the liver and improving bioavailability.
 To inhibit pre-systemic enzyme activity, notably from the P450 enzymes, that can
increase the cellular concentration of the drug.
 Our controlled release technology, offer a solution for pharmaceutical actives that
require controlled release, abuse deterrent properties and environmentally stimulated
release. Tailored to your needs, our technology is capable of loading even difficult to
load actives.
4. Delivery Enhancement Technology

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Application for generic approval or potential therapeutic molecule under regulatory bodies
requires the demonstration of a bioequivalent product or proof of concept for approval. This
means that the blood levels of the active ingredient need to show that the product is highly
similar in innovator composition in case of generic and therapeutic activity better than existing
therapy line. Innovator’s formula as it is proprietary, contents are not revealed by the agency.
Stabicon team has handled of reverse engineering services for Q1 (Qualitative) and Q2
(Quantitative) equivalency of topicaloral products for IVRT Equivalence efficacy studies (Q3)
based on Regulatory Guidance & BCS classification system. Expertise is summarized in the table
below:
Sr. No. Route Q1 (Qualitative) Q2 (Quantitative) Q3 (Delivery Action )
1 Topical & Transdermal feasible feasible feasible
2 Oral Dosage forms feasible feasible feasible
5. Formulation Reverse Engineering

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Figure: Example Representation of reverse engineering approach for Product
Formulation.

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6. Antimicrobial Screening & Dosage Development Program

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Potential Source - AMR

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Program Offered
1. Centralized stability center for global market
2. Centralized analytical & Microbiology support for MD & MV
3. Third party product certification
Section-7a: Physical Analysis Capabilities
Sr. No Test Parameter
1 Uniformity of Weight / Weight Variation
2 Uniformity of Dosage Units (by weight)
3 Uniformity of Dispersion
4 Diameter / Thickness / Length / Width (For each )
5 Hardness
6 Disintegration test
7 Friability test
8 Loss on Drying / LOD
9 Dispersion
10 Bulk density
11 Jelly strength
12 Particle size(Microscopic)
13 Specific surface area
14 Bloom strength
15 Crystallinity
16 Particulate matter
17 Redispersability
18 Deliverable volume
19 Content of packed dosage form
20 Wetting time
21 Volume in container
22 Tapped density (Manual)
23 Sieve analysis per sieve /30 mesh size,20 mesh size
7. Laboratory & Stability Program

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Section-7b: Chemical Analysis Capabilities
Sr. No Evaluation parameter
1 Loss on Ignition / sup hated Ash
2 Heavy metals
3 Arsenic
4 Melting point / melting range
5 Acidity / alkalinity
6 Total hardness
7 Total dissolved solids
8 Color / Clarity of Solution (Chemical)
9 Chlorides, by Titration
10 Chlorides (qualitative test)
11 Sulphates/Sulphites , by Titration / Gravimetry
12 Sulphates/sulphites (qualitative test)
13 Solubility in water
14 Solubility in solvents (each)
15 Density /Specific gravity (weight per ml)
16 Identification by Chemical
17 Distilling range
18 Assay by chemical
19 Residue on evaporation
20 Assay by aqueous titration
21 Assay by Non Aqueous Titration
22 Uniformity of Content by Chemical
23 Iodine value
24 Saponification value
25 Acid value
26 Peroxide value
27 Volatile oil content
28 Cyanide content
29 Potassium content
30 Sodium content
31 Freezing point
32 Nitrogen determination-Kjeldhal method
33 Reducing sugars (Reducing sugars before hydrolysis) (Based on Method)
34 Aldehydes and reducing substances (Based on Method)
35 Reducing sugars after hydrolysis (Based on Method)
36 Esters

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37 Lead
38 Nickel
39 Congealing temperature
40 Sucrose analysis by Titration (Based on Method)
41 Calcium and Magnesium
42 Fluoride (Based on Method)
43 Ammonium
44 Reducing impurities
45 Dextrin
Section-7c: Instrumental Analysis Capabilities
1 Identification by HPLC -UV detector
2 Identification by HPLC -RI detector
3 Identification by GC-FID detector
4 Amino acid analysis by HPLC-UV detector
5 Identification by IR
6 Identification by TLC
7 Identification by UV
8 Optical Rotation by Digital Polari meter (Specific optical rotation)
9 Assay by HPLC -UV detector /UPLC-PDA
10 Assay by HPLC -RI detector
11 Assay by GC-FID detector with head space
12 Assay by GC-FID detector without head space
13 Assay by UV
14 Assay by TLC
15 Dissolution by HPLC /UPLC-PDA
16 Dissolution by UV / Chemical, for Single Time Point
17 Preservative content by UPLC
18 Preservative content by HPLC-UV detector//UPLC-PDA
19 Preservative content by HPLC-RI detector
20 Uniformity of content by UPLC
21 Uniformity of Content by HPLC-UV detector
22 Uniformity of Content by HPLC-RI detector
23 Uniformity of Content by UV / Chemical
24 Related substances / Compounds by HPLC UV detector /UPLC-PDA
25 Related substances / Compounds by HPLC RI detector /UPLC-PDA
26 RS by GC FID Detector with head space

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27 RS by GC FID Detector without head space
28 Organic Volatile Impurities (Up to four) by GC-FID detector
29 Potentiometric titration
30 Related substances/TLC
31 Forced Degradation Study as per ICH (5 degradation Pathways)
Section-7d: Microbiological Analysis Capabilities
1 Preservative Efficacy Testing (Five Microorganisms with five intervals)
2 MLT Validation (Per Microorganism)
3 MLT Verification(Per Microorganism)
4 BET
5 Environmental Monitoring Analysis
6 BET Validation & Verification
7 Organism Identification (Gram staining -per colony)
8 Organism Identification (Lacto phenol cotton blue staining -per colony)
9 Organism Identification (Acid fast staining-per colony)
10 Water analysis(Raw water, Untreated process water, Treated Process water)
11 Preservative Efficacy Testing ,Validation, Verification, Assay, Dissolution Study
Section-7d.1: Bioburden Analysis Capabilities
1 Bioburden test
2 Bioburden validation
Section-7d.2: Microbial Limit Analysis Capabilities
1 Microbial limit test
2 Microbial limit test validation & verification
Section-7d.3: Sterility Analysis Capabilities
1 Sterility test
2 Sterility test validation & verification

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Section-7d.4: Antimicrobial Activity Studies
1 Kirby Bauer Disc method
2 Minimum inhibitory concentration
3 Agar plug diffusion method
4 Agar well diffusion method
5 Cross streak method
6 Agar diffusion
7 Dilutions methods
8 Time kill rate study
Section-7d.5: Others
2 Disinfectant Qualification test
3 Disinfectant efficacy studies
4 Environmental Monitoring
5 Water analysis
6 Enzyme Activity study (Invitro)
7 Bacterial Endotoxin test
10 Bacteriostatic/Fungi stasis
11
Study of the pepsin Enzymatic activity in Invitro dissolution test by UV/VIS
Spectrophotometry
Section-7e: Comparative Dissolution Profiles
1 Development of discriminating dissolution Method by HPLC/UPLC
2 Development of Discriminating Dissolution Method by UV
3 CDP (Test & Reference), 4 Time Points up to 4 media, BY HPLC
4 CDP (Test & Reference), 4 Time Points up to four media, BY UV

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Section-7f: Method Development
S.N Evaluation parameter
1 Method Development for Assay / UOC by HPLC/UPLC/Microbial
2 Method Development for Assay / UOC by UV
3 Method Development for Dissolution by HPLC/UPLC
4 Method Development for Dissolution by UV
5
Method Development for Related Substances / Compounds by HPLC
Forced Degradation, by HPLC/UPLC
6
Method Development for Related Substances / Compounds by HPLC, without Forced
Degradation, by HPLC/UPLC
Section 7g: Method Validation, as Per ICH
1 Method validation for Assay by HPLC/UPLC with Forced Degradation
2 Method validation for Assay by HPLC, without Forced Degradation
3
Method validation for Dissolution / Preservative Content / Content by HPLC/UPLC
4
Method validation for Assay / Dissolution / Preservative Content
5
Method validation for Related Substances / Compounds by HPLC, with Forced
Degradation
6
Method validation for Related Substances / Compounds by HPLC, without Forced
Degradation
7 Method validation by GC-FID
Section-7h: Method Development & Validation as Per ICH
1 Method development & validation for assay by HPLC, with Forced degradation
2
Method development & validation for Assay by HPLC, without forced
Degradation
3
Method development & validation for Dissolution / Preservative content /
Colorant / UOC by HPLC/UPLC
4
Method development & validation for assay / dissolution / preservative
content / colorant / UOC by UV
5
Method development & validation for Related Substances / compounds by
HPLC, with Forced Degradation/UPLC

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Section-7i: Method Transfers / Verifications
1 Assay by HPLC/UPLC
2 Assay by UV / Chemical
3 Assay by Microbiology / Antibiotic Assay
4 Dissolution by HPLC
5 Dissolution by UV
6 Related Substances / Compounds by HPLC/UPLC
Section-7j: Stability Storage
1 Storage - ICH Conditions
2 Storage - Photo stability
3 Storage - Freeze thaw stability
4 Storage - Sync accelerated stability
5 Full time equivalent service model and Fixed rate contract service model
6 Retention sample /Backup storage/Disaster management storage
7 Controlled substance & Products evaluation
8 Import License

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We provide concept-to-completion design laboratory and formulation development Centre for
pharmaceutical industry. Our experts will understand your business, possess experience
implementing best practices, and will leverage that expertise to enhance your lab's and R&D
efficiency. Whether it’s for research or routine testing, our experts can recommend and provide
the right solution to address laboratory and development process challenges, helping you drive
decisions, maximize resources, and increase productivity. Our operational set up services will
ensure regulatory compliance and efficient workflows within a facility. Details of services as
follow.
Sr. No Capabilities
1 Needs assessment
2 Process Improvement
3 Complete Automation of process
4 Plan & setting up operation center
5 Multicenter integration process
6 Training programs – Onsite & Offsite Program
7 Expert Laboratory Personnel Training
We will be pleased to talk to you through voice or email, for better understanding of your
requirements.
8. Turnkey & Training

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Poor medicine quality can sometimes lead to serious health consequence & death.
Imported or Locally Manufactured Medicines without proper pre & post
inspection may be rendered substandard at any point along the medical supply
chain, from the point of manufacture through the point of distribution. Regardless
of where along the supply chain substandard medicines are compromised, they
pose serious public health risks. Use of substandard medicines increases
mortality and morbidity and may result in harmful side effects or allergies or
engender drug-resistant pathogens that limit the therapeutic effectiveness of
legitimate medicines. if contaminated with pathogens result in death.
Substandard medicines undermine governments’ investments in health delivery
systems. They erode citizens’ trust in their governments’ ability to maintain and
enforce regulatory standards. Their spread also undermines governments’
credibility with respect to providing quality health care. Regulatory body/
Organization Partnering with Stabicon support assist to can address the above
challenges by following approaches:
9. Referral Lab

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For any query please contact:
info@stabicon.com
Team Business Development
+91 80 27839259/27839260
bd@stabicon.com

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