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Business Portfolio Business Portfolio By Business Development Team Stabicon Life Sciences FY 2019-2020 Stabicon Business Portfolio www.stabicon.com Life Sciences Index Sr. Business Segment Services Portfolio Page No 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 Business Development Email:[email protected] 1 Stabicon Business Portfolio www.stabicon.com Life Sciences 1. Formulation Development – Dosage Form Sr. No Drug delivery system Type Dosage form Pill Tablet Capsule Oral Delivery through Digestive 1 Solids Lozenges & Pastille tract(enteral) Buccal & sub lingual Tablets Osmotic delivery system (OROS) Granules, Powder Spray Drops Ointment Hydrogel Solid/Semi- 2 Ophthalmic /Otologic / Nasal solid/Liquid Insufflation Mucoadhesive micro disc (microsphere tablet) Ointment Pessary (vaginal suppository) Extra-amniotic infusion Solid/Semi- 3 Urogenital Tablets solid/Liquid Intravesical infusion Ointment Suppository Enema Solution Solid/ Semi- 4 Rectal (enteral) Hydrogel solid/Liquid Murphy drip Nutrient enema Ointment Topical gel Liniment Solid/ Semi- Paste 5 Dermal solid/Liquid Film Business Development Email:[email protected] 2 Stabicon Business Services Portfolio www.stabicon.com Life Sciences Film DMSO drug solution Hydrogel Liposomes 5 Dermal Transfer some vesicles Cream Lotion Medicated shampoo Dusting Powder Solutions Suspensions Emulsions 6 Parenteral Dry powders filled into vials (to be reconstituted) Lyophilized dosage forms Preservative free 3 Confidential Document Email:[email protected] Stabicon Business Portfolio www.stabicon.com Life Sciences 2. Brand Extension Form 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 Business Development Email:[email protected] 4 Stabicon Business Portfolio www.stabicon.com Life Sciences 3. Biowavier - In-vitro Program Section-3a: Invitro Studies for Nonsystematic Drugs Sr. No Molecule Route Applications Suspension/ Oral Anti-cholesterol (Bile acid 1 Cholestyramine (Light/Regular) Sequestrate Tablet/Suspension: oral Anti-cholesterol (Bile acid 2 Colesevelam hydrochloride Sequestrate Granule; Oral Anti-cholesterol (Bile acid 3 Colestipol hydrochloride Sequestrate 4 Sevelamer hydrochloride Suspension; Oral Renal (Phosphate Binding) 5 Sevelamer Carbonate Tablet/Suspension; Oral Renal (Phosphate Binding) Chewable Renal (Phosphate Binding) 6 Lanthanum Carbonate Tablets/Oral/Suspension & Kinetics 7 Calcium Acetate Tablets/Oral Renal (Phosphate Binding) Powder; oral/rectal Renal (K+ Binding) 8 Sodium polystyrene sulfonate Powder; oral/rectal Renal (K+ Binding) 9 Calcium polystyrene sulfonate Tablet/Suspension: oral Renal (K+ Binding) 10 Sucroferric Oxyhydroxide Granule; Oral Renal (K+ Binding) 11 Ferric Citrate Suspension/ Oral Duodenal ulcer(Bile acid 12 Sucralfate and protein binding & pepsin inhibition) Business Development Email:[email protected] 5 Stabicon Business Portfolio www.stabicon.com Life Sciences Section -3b: Nasogastric and Gastronomy (NG) Tube Invitro Studies Sr. No Molecules Route Applications Delayed Release 1 Lansoprazole DR Capsule Proton pump inhibitor Capsule/Oral Esomeprazole Strontium DR Capsule, Delayed Release; 2 Proton pump inhibitor Capsule Oral Esomeprazole magnesium DR Capsule, Delayed Release 3 Proton pump inhibitor Capsule Pellets; Oral Extended Release Capsule; 4 Morphine Sulfate Pain management Oral 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 Business Development Email:[email protected] 6 Stabicon Business Portfolio www.stabicon.com Life Sciences 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 Business Development Email:[email protected] 7 Stabicon Business Portfolio www.stabicon.com Life Sciences 4. Delivery Enhancement Technology 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. Business Development Email:[email protected] 8 Stabicon Business Portfolio www.stabicon.com Life Sciences 5. Formulation Reverse Engineering 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 topical\oral 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 Business Development Email:[email protected] 9 Stabicon Business Portfolio www.stabicon.com Life Sciences Figure: Example Representation of reverse engineering approach for Product Formulation. Business Development Email:[email protected] 10 Stabicon Business Portfolio www.stabicon.com Life Sciences 6. Antimicrobial Screening & Dosage Development Program Business Development Email:[email protected] 11 Stabicon Business
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