Formulation Development of New Chemical Entities (NCEs) Dr. Mariella Artusi Pharmaceutical Development Dept. Monza

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1 Formulation Development of New Chemical Entities (NCEs) Dr. Mariella Artusi Pharmaceutical Development Dept. Monza HorizonChem 2018, March, 6th

2 Content Rottapharm Biotech : Company Overview Formulation Development: Definition&Glossary Target Product Profile Introduction to «Biopharmaceutics» Formulation Development Pre-clinical Phase Clinical Phase Marketing Conclusions HorizonChem 2018, March, 6th

3 Company Profile- overview Rottapharm Biotech (RPHB) is an R&D company dedicated to innovative drug discovery. Spin-off of the former R&D division of Rottapharm Madaus, of which it retained the whole capabilities, infrastructures, and innovative drug discovery programs and assets. Mixed model involving innovative new chemical entities (NCEs; small molecules) and biotherapeutics including monoclonal antibodies. Large expertise in different therapeutic areas, especially rheumatology and gastroenterology, but also gynaecology, bronchopneumology, cardiovascular and metabolism disorders, and Central Nervous System. RPHB business model consists of a flexible approach where drug development is carried out mainly on internal proprietary discoveries, but also on external projects deriving from early-stage in-licensing or other forms of collaboration. Opportunities for out-licensing are considered during any development phase, but are pursued systematically after the clinical proof of concept has been achieved HorizonChem 2018, March, 6th 2018

4 Formulation Development - Definition - Part of Drug Development (DD) of New Active Substance being the process that brings an optimized lead candidate from Medicinal Chemistry/Biotherapeutic laboratories to the market. Applies to NCEs and Bioterapeutics DD Aim: design a Quality Product and its manufacturing process to consistenly deliver the intended performance of the product. Duration: approx 10 years Regulatory Initiatives were introduced in last decades as useful approach providing a better understanding of the product and assuring its quality - Good Manufacturing Practices (GMP) - Quality by Design (QbD) - Process Analytical technology (PAT) - Quality System HorizonChem 2018, March, 6th

5 Formulation Development - Glossary - Active Pharmaceutical Ingredient (API)/Drug Substance (DS) Any substance or combination of substances used in a finished pharmaceutical product, intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings." Dosage Form/Drug Product (DP) Mean by which API are delivered to site of action within the body. It gives shape and mass to the API allowing the administration thruogh the most appropiate route at the desired dose. - Made of API+excipients - Different Administration Routes - Conventional/Traditional: Immediate release of API - Modified Release: Prolonged/sustained/..release of API. Excipients: Any ingredient other than API which is intentionally added to dosage form, without therapeutic effect, to improve Manufacturability In vivo performance (i.e. release of API) HorizonChem 2018, March, 6th

6 «Target Product Profile (TPP)»* First Intent of «early» Drug Development process Fundamental input data: - Indication and usage - Administration route - Preferred dosage form - Dosage regimen (acute? chronic?) - Desired API release profile (once daily?) - Target population (age, sex?) - Contra-indications - Clinical studies planning Marketing requirements (vs gold standard?) - Dynamic tool *In particular, TPP was originated in 1997 by FDA, as a planning tool for the development of a drug candidate from discovery to clinical development programs, Not mandatory but facilitating contact between companies and FDA HorizonChem 2018, March, 6th

7 Biopharmaceutics: Introduction (i) Biopharmaceutics «the study of the factor influencing rate and amount of drug that reach systemic circulation and the use of this information to optimize the therapeutic efficay of drug product» Pharmocokinetics (PK): scientific branch dedicated to determine the fate of substances administered to living organism (animal species and human) Biopharmaceutics and PK deal with LADME where: - L is the Liberation of API from dosage form: Biopharmaceutics - ADME (Absorption, Distribution, Metabolism, Excretion): PK Formulation Development, supported by Biopharmaceutics, acts on fate of API before absorption Once absorbed, the fate of API is matter of Pharmacokinetics HorizonChem 2018, March, 6th

8 Biopharmaceutics: Introduction (ii) The API is absorbed only when dissolved The in vivo performance of orally administered drug depends upon their solubility and tissue permeability characteristics HorizonChem 2018, March, 6th

9 Formulation Development-Pre-clinical Phase (i) Synthetic chemists may record some data but: API batches during early development phase are not consistent each others API Scale-up process could be modified (impurities profiles etc..) Mainly consisting in preformulation studies focussing on the screening physico-chemical properties/parameters of a NCE impacting on: Development and manufacturing of dosage form In vivo Performance (efficacy, safety) Translating to «biopharmaceutics» concept: preformulation generates information useful to guarantee the availability of drug for absorption according target «in vitro» testing to predict «in vivo» beahviour different formulation=different release API=different onset/duration of effect develop an elegant, stable, bioavailable and safe dosage form Identification of «quality critical attributes» recognised as the ones to be stricly controlled during manufacturing to ensure the quality of the final product (safety and efficacy) HorizonChem 2018, March, 6th

10 Pre-clinical Phase (ii) Parameter Comment Potential Impact Solubility (thermodynamic) Dissolution rate (dynamic) Water and ph solubility profile Gastro-intestinal (GI) simulated Fluids solubility (SGF, FaSSIF, FeSSIF) Rate at which API dissolves in a medium Manufacturability (liquid dosage forms) Absorption /GI precipitation Dissolution of API after administration-critical for availability pka Effect of ionization on solubility Solubility/Potential for Salt formation Salt Version Solid State Different salt of the same API SALT SELECTION PROCESS: in situ tecnique Amorphous/Polymorphism different polymorphic forms, solvates (pseudopolymorphism), hydrates POLYMORPH SCREENING PROCESS Stability of dosage forms Solubility of API Stability of API and dosage forms Solubility of API Manufacturability of API Manufacturability of dosage forms Hygroscopicity Deliquescient? Manufacturability consideration-controlled temperature and humidity Partition coefficient/logp Lipophilicity Manufacturability consideration Permeability Responsibility of PK Absorption through membranes Stability Particle size and shape (morphology) Solid and liquid phase stability Biorelevant media stability Photostability Polymorphic forms Shelf life od Dosage forms Packaging requirements API dissolution rate and solubility Density, flowability of bulk powder Batch to batch inconsistency Organoleptic properties Color, odor, taste Batch to batch inconsistency Unpalatability HorizonChem 2018, March, 6th Difficulty in blinding operations

11 Pre-clinical Phase (iii) Desiderable attributes of API Crystalline (most stable form) Manufacturable with high batch to batch consistency Acceptable solid/liquid state stability Stable under technological operations (tabletting, granulation, lyophilization etc..) Not hygroscopic Not high coloured or strong odour Compatible with key excipients Acceptable solubility along GI tract HorizonChem 2018, March, 6th

12 Pre-clinical Phase (iv) During preclinical phase, the formulator is asked to design formulation to support preclinical studies in animals PK study: to assess ADME (low doses) Toxicological study: to assess safety profile (high doses) 2 animal species Resulting formulation are simple but «engineered» in order to maximize the absorption of API Preferred formulation are solution - Use of excipient capable to mantain dissolved the API - Flexible over wide dose range (up to very high doses) - Easy to be administered in animals - Not always suitable for human use HorizonChem 2018, March, 6th

13 Clinical Phase (i) Preclinical research answers basic questions about drug s safety, it is not a substitute for studies of ways the drug will interact with the human body Aim: to assess safety and efficay in human volunteers Investigational Medicinal Product (IMP) could be tested vs: - Placebo - Comparator Clinical Studies has to authorized by Competent Authorities, upon approval of appropiate documentation PHASE STUDY PARTICIPANTS LENGHT PURPOSE % MOVING NEXT PHASE 20 to 100 healthy volunteers or Several months Safety and dosage (from pre-clinica data) 70 I people with the disease/condition. Doseing scheme based on animal data. Single administration II PROOF of CONCEPT III Up to several hundred people with the disease/condition. 300 to 3,000 volunteers who have the disease or condition Several months to 2 years Prove of efficacy No large enough to show whether the drug will be beneficial. Phase 2 studies provide researchers with additional safety data. 1 to 4 years Researchers design Phase 3 studies to demonstrate whether or not a product offers a treatment benefit to a specific population. Sometimes known as pivotal studies. Phase 3 studies provide most of the safety data IV Several thousand volunteers who have the disease/condition Post-Market Safety Monitoring HorizonChem 2018, March, 6th

14 Clinical Phase (ii) IMP «desiderata» - Easy to be dosed also as multiple administration - Delivery of the drug according clinical needs - Flexible to cover wide range of doses (1 mg up to..) - Easy to be blinded vs placebo and/or comparator - Manufactured consistently over time - Typically, for first phases, are Immediate Release Dosage Forms - Stable IMP Requirements (MANDATORY) - Manufactured and analyzed according GMP in certified company and labs - Compliant with pre-defined acceptance criteria range (Specifications) It is highly reccomended to face the entire clinical studies phase with the SAME dosage forms (time and cost) If a change is needed, human bridging studies with previous formulation are mandatory to re-assess the dosing regimen (safety concern) HorizonChem 2018, March, 6th

15 Marketing By the time of phase III clinical trials are reached, the formulation of the drug should have been developed to be close to the preparation that will ultimately be used in the market. A deep knowledge of manufacturing process and analytical method for testing is required Validation to demonstrate the robustness of process is mandatory The stability of dosage form is essential by this stage, and conditions must have been developed to ensure that the drug is stable in the preparation (i.e. primary packaging) Brand name selected according defined procedures Selection of secondary packaging (i.e. cartoon box or ) and artworks is mainly part of marketing strategy Once DP is on the market.opportunity for Product Line Extension to support new market needs HorizonChem 2018, March, 6th

16 Conclusions «Lipinsky rule» No more than 5 hydrogen bond donors (the total number of nitrogen hydrogen and oxygen hydrogen bonds) No more than 10 hydrogen bond acceptors (all nitrogen or oxygen atoms) A molecular mass less than 500 daltons An octanol-water partition coefficient log P not greater than 5 An unique rule for identify a «developable» drug product doesn t exist, so far Developability profile of NCE/biotherapeutic has to be fully characterized since very early phase- at time of candidate selection, hopefully Formulation issues can be fixed/mitigated as soon as possible (time, resorces and cost) A strong collaboration with other disciplines is required to reach the target product «Formulation Development» is a challenging & engaging work! HorizonChem 2018, March, 6th

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