SUSTAINED RELEASE TABLETS USING A PVA DC FORMULATION RESISTANT TO ALCOHOL INDUCED DOSE DUMPING

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1 SUSTAINED RELEASE TABLETS USING A PVA DC FORMULATION RESISTANT TO ALCOHOL INDUCED DOSE DUMPING Dr. Dieter Lubda MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany

2 Agenda: Sustained release tablets using a PVA DC formulation resistant to alcohol induced dose dumping Introduction Why/ what are sustained release tablets? 1 Case study (sustained release tablets) 3 2 Tablets by using PVA DC formulation Case study (alcohol induced dose dump) What is dose dumping? Wrap-up and summary: Sustained release 2 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

3 3 INTRODUCTION WHY/ WHAT ARE SUSTAINED RELEASE TABLETS?

4 Daily pill burden: (Immediate vs Sustained Release) Immediate Release Sustained Release 4 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

5 Fast-/ Sustained-Release Schematic drawing of plasma concentration-versus-time profiles following administration of different types of controlled-release dosage forms Toxic Ineffective 5 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

6 Types of modified release dosage forms Definitions based on EMA guidelines Modified release dosage forms Release of the API(s) at a rate or place different from that of the conventional (immediate release) dosage form. Modified Release Sustained Release Sustained release (Extended release, Prolonged release dosage forms) Dosage forms showing a slower release than that of the conventional release dosage form. Delayed release dosage forms The release of the active substance is delayed for a predefined period after administration. Delayed Release Multiphasic Release Multiphasic or programmed release dosage forms e.g. pulsatile release: intended to deliver a burst of drug release at specific time intervals. 6 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

7 Pros & Cons of Sustained Release 1 Advantages 2 Challenges Reduced dosing frequency Better patient acceptance and compliance Reduced GI side effects Reduced potential for accurate dose adjustment Need of additional patient education Stability problems Less fluctuation at plasma drug levels Well characterized and reproducible dosage form Improved efficacy/ safety ratio (total dose is low) Fate (interaction) of polymer Dose dumping Biocompatibility 7 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

8 Drivers for Sustained Release dosage forms Therapeutic Drivers Commercial Drivers Sustained & consistent blood level within the therapeutic window Reducing side-effects Reducing dosing frequency Improving patient compliance Optimizing performance Prolonging action Minimizing variability Enhanced bioavailability Lifecycle management of patented drugs Reformulation of marketed drugs Bypassing IP hurdle 8 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

9 Overview of common approaches to modified release formulations Modified release Delayed Sustained Multiphasic / programmed Site-specific / Targeted Triggered Enteric coating Matrix systems Reservoir systems Osmotic systems Osmotic Ion systems exchange mechanisms Ion exchange other mechanisms other Combination of immediate + extended or delayed + extended components Prodrugs / Conjugates Biodegradable carrier / coating ph sensitive coating / matrix Eroding coating Swelling / osmotically controlled systems Bioadhesive systems ph Temperature Electrostimulation Magnetism 9 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

10 Approaches to modified release formulations Matrix systems Swelling and Diffusion Diffusion and Dissolution / Erosion Benefits Cost-effective and easy to scale up Performance adjustable (polymer type, grades thereof, quantity) Generally lower risk of dose dumping Dosage forms divisible (dose adjustment) Drawbacks Typically a first-order release profile Due to changing surface area and diffusion layer One single polymer does not suit all drugs 10 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

11 Matrix systems: Sustained release formulations Hydrophilic matrices Non-ionic cellulose ethers (e.g. HPMC, HPC, HEC) Nonionic homopolymers of ethylene oxide (e.g. PEO) Water-soluble natural gums of polysaccharides (e.g. xanthan gum, alginate) Water swellable, insoluble homo- and copolymers of acrylic acid Hydrophobic matrices Fatty acids and derivatives Fatty alcohols Waxes of natural and synthetic origin (e.g. polyethylene) Hydrophobic polymers (e.g. ammoniomethacrylate copolymers) Polyvinyl acetate and povidone mixtures 11 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

12 12 TABLETS BY USING PVA DC FORMULATION

13 What excipient did we use for the study? Functional excipient for sustained release oral solid dose formulations 100 % Poly(vinyl alcohol), fully synthetic, milled, with specified medium particle size n OH SEM 10,000x Parteck S R P 80 Particle technology particle engineered product range Sustained Release Polyvinyl alcohol (PVA) Medium particle size in µm 13 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

14 Material characteristics Material Bulk density Tapped density Poly-vinylalcohol pharma grade g/ml g/ml Angle of repose Mean particle size µm (laser diffraction Dv 50 ) (target ~ 80 µm) Surface (N 2 -adsorption S BET ) Pore volume (N 2 -adsorption S BET ) m²/g not detectable Loss on drying (3h, 105 C) 5.0% Optimized particle size regarding compressibility Optimized particle size regarding drug dissolution Compliant with Ph. Eur., USP, JPE monographs Emprove Low content of croton aldehyde specified 14 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

15 Main benefit 1: Synthetic product 1 Excipient used for the study 2 Poly-vinylalcohol with optimized mean particle size Fully synthetic and chemically defined product Established solutions to-date Very often cellulose based polymers Thus naturally derived products Batch to batch consistency Consistent quality of the excipient supports estabisment of Quality by Design (QbD) QbD helps to minimize risks in development and manufacture Batch to batch variability Challenges in formulation and production processes May affect release performance of final product Inconsistent excipient quality poses a challenge to QbD implementation Excipient supports a consistent final product quality and Quality by Design. 15 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

16 Main benefit 2: Cost-savings by direct compression 1 PVA based excipient 2 Other processes used Suitable for direct compression (shown in combination with MCC) Typically complex, multiple-step processes DC = Direct compression Tablet Mixing Compression Wet granulation Mixing Wetting Granulation Drying Coating Wet granulation or direct compression Tablet Multiparticulates Mixing Wetting Extrusion Spheronization Drying Sieving Mixing Coating Coated tablet Filling into capsule or tabletting process Tablet Compression Tablet / Capsule Substantial process cost savings through simple and economic process 16 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

17 Process costs: Wet granulation vs. direct compression Wet granulation Process cost ( /kg)* Process cost ( /kg)* Direct compression 1. Weighing of ingredients 2. Blending of ingredients 3. Prep. granulation fluid 4. Granulation 5. Wet sieving 6. Drying process 7. Dry sieving process 8. Add. of external phase /kg /kg /kg /kg /kg /kg /kg /kg /kg /kg 1. Weighing of ingredients 2. Blending of ingredients TOTAL /kg /kg TOTAL Compression to tablets Potential reduction of 6 additional steps Total cost reduction up to 75%** * process cost was estimated based on available production data and own experience ** depending on the formulation/process 17 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

18 18 CASE STUDY WITH SUSTAINED RELEASE TABLETS

19 General formulation with PVA based excipient Amount in % (w/w) Active ingredient 5 50 PVA Excipient (Parteck SRP 80) Microcrystalline cellulose Silicon dioxide, highly dispersed Parteck LUB MST TOTAL 100 The PVA excipient content of the formulation should not be less than 20 % (w/w), otherwise gel forming will be inhomogeneous. The choice of the microcrystalline cellulose may have an effect on the galenical properties of the resulting tablets. The PVA excipient is designed for the formulation of sustained release oral dosage forms, and is well suitable for direct compression processes. 19 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

20 Mode of SR action Matrix tablet before wetting Matrix tablet after wetting: swelling and surface erosion visible 20 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

21 Release [%] Mode of SR action 12 End = Tablet is mainly dispersed Visual Tracking 9 Dissolution Time 12 Hours 6 3 Dissolution Measurement time [h] N = 3 ± sd Detection: UV 244nm 21 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

22 Case study 1 API = Propranolol HCl Pharmaceutical use Hypertension Heart rhythm disturbances Coronary heart disease Prevention of repeated myocardial infarction Physico-chemical & physiological properties Well soluble and permeable (BCS I) Therapeutic window has to be ensured, otherwise inadequate efficacy or dangerous toxic effects For consistent effective treatment within therapeutic window, a sustained drug release over longer time periods is crucial 22 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

23 Case study 1 Formulation details Propranolol HCl Components Amount [mg] Amount [%] Propranolol HCl PVA Excipient MCC SiO 2, highly dispersed Function Model API Hydrophilic matrix polymer Binder/ Diluent Flow Regulator Parteck LUB MST Lubricant Total Manufacturing process PVA Excipient and MCC are pre-mixed for 10 minutes in a tumbling mixer. API and silicon dioxide are added, mixed again for 10 minutes and sieved over 800 µm sieve to destroy agglomerates. Parteck LUB MST is sieved through a 250 µm sieve onto the mixture. All components are blended again for 5 minutes. Direct compression at 5, 10, 20 & 30 kn (500 mg tablets, Ø 11 mm, flat, facetted) 23 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

24 Tablet hardness [N] Ejection force [N] Case study 1 Compressibility and Ejection force Diagram: Compressibility and ejection force Legend PVA Excipient example formulation tablet hardness [N] 278 PVA Excipient example formulation ejection force [N] Compression force [kn] 0 Tablet hardness was measured with n = 20 The example formulation with PVA excipient shows high compressibility and low ejection forces over a vast range of compression forces. 24 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

25 % of propranolol HCl dissolved Case study 1 Release profile Broad range of compression forces Release profiles different compression forces Legend Compression forces 10kN / 20kN / 30kN Example formulation compression force 10 kn tablet hardness 150 N Example formulation compression force 20 kn tablet hardness 278 N Example formulation compression force 30 kn tablet hardness 318 N Time [h] Dissolution procedure: USP Apparatus 2 (Paddle Apparatus), 900 ml phosphate buffer ph 6.8, 50 rpm, 37 C, detection wavelength 214 nm; n=3 PVA excipient shows a constant in-vitro release behavior over a broad range of compression forces and resulting tablet hardnesses 25 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

26 % of propranolol HCl dissolved Case study 1 Release profile Comparison with commercial product Diagram: Dissolution comparison with commercial product Legend Example formulation compression force 20 kn tablet hardness 278 N Commercial product Time [h] Dissolution procedure: USP Apparatus 2 (Paddle Apparatus), 900 ml phosphate buffer ph 6.8, 50 rpm, 37 C, detection wavelength 214 nm; n=3 The commercial product is a formulation of controlled release pellets in a hard gelatin capsule. Concentration:160 mg of API which is equivalent to the example formulation with Parteck SRP 80. The example formulation with PVA excipient shows a very similar release profile to commercial product. 26 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

27 % of propranolol HCl dissolved Case study 1 Stability data Stability after 12 months under different conditions Legend t=0 25 C/60% r.h., closed, after 4 months 25 C/60% r.h., opened, after 4 months 40 C/75% r.h., closed, after 4 months 40 C/75% r.h., opened, after 4 months 25 C/60% r.h., closed, after 12 months 25 C/60% r.h., opened, after 12 months 40 C/75% r.h., closed, after 12 months 40 C/75% r.h., opened, after 12 months Time [h] Tablets shows no change of in-vitro release after 12 months of storage, even under stress conditions. USP Apparatus 2 (Paddle Apparatus), 900 ml phosphate buffer ph 6.8, 50 rpm, 37 C, detection wavelength 214 nm; n=3 Samples used: tablets compressed at 20 kn 27 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

28 Case study 2 API Diltiazem HCl Pharmaceutical use Hypertension Angina pectoris Certain types of arrhythmia Physico-chemical & physiological properties well soluble and permeable (BCS I) therapeutic window has to be ensured, otherwise inadequate efficacy or dangerous toxic effects (blood pressure/heart rate, dizziness, AV block) Diltiazem HCl To ensure an effective treatment within therapeutic window and reduce the risk of side effects, a sustained release formulation is crucial. 28 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

29 Tablet hardness [N] Ejection force [N] Case study 2 Compressibility and Ejection force Diagram: Compressibility and ejection force Legend Example formulation tablet hardness [N] Example formulation ejection force [N] Compression force [kn] 0 Tablet hardness was measured with n = 20 The example formulation shows high compressibility and low ejection forces over a vast range of compression forces. 29 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

30 % of diltiazem HCl dissolved Case study 2 Release profile Comparison with commercial product Dissolution comparison with commercial product Legend PVA Excipient example formulation compression force 20 kn tablet hardness 211 N Commercial product tablet hardness 97 N Dissolution procedure: Time [h] Dissolution procedure: USP Apparatus 2 (Paddle Apparatus), 900 ml phosphate buffer ph 7.2, 50 rpm, 37 C, detection wavelength 237 nm; n=3 The commercial product contains 90 mg of API which is equivalent to the example formulation with Parteck SRP 80. It is a tablet formulation based on carboxymethylcellulose sodium and HPMC. The example formulation shows a similar release profile to the commercial product over a broad range of compression forces and tablet hardnesses. 30 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

31 Benchmarking Material properties Material Bulk density [g/ml] Tapped density [g/ml] Angle of repose Loss on drying (3h, 105 C) PVA Excipient 100% PVA Excipient A Excipient B Excipient C 100% HPMC 100% HPMC 100% HPMC (good) 42.1 (passable) 36.9 (fair) 42.2 (passable) Optimized particle size for direct compression and dissolution properties Higher bulk and tapped density gives smaller tablets Low angle of repose supports lower tablet weight variations Lower loss on drying value for better stability The typical technical data above serve to generally characterize the excipient(s). These values are not meant as specifications and they do not have binding character. 31 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

32 Change of mass [%] Benchmarking Hygroscopicity Diagram: Dynamic vapor sorption isotherm at 25 C Parteck SRP 80 Excipient A Excipient B Excipient C Rel. humidity [%] Parteck SRP 80 shows lower hygroscopicity in comparison to HPMC based excipients, resulting in better handling and improved stability. 32 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

33 Tablet hardness [N] Benchmarking Compressibility Tablet hardness vs compaction force Placebo formulation: Parteck SRP 80 Excipient A Excipient B Excipient C Compaction force [kn] % PVA Excipient (Parteck SRP 80) or HPMC % MCC 0.25 % Silicon dioxide, highly dispersed 0.25 % Parteck LUB MST Direct compression using different compaction forces (500 mg tablets, Ø 11/13 mm*, flat, facetted) Tablet hardness was measured with n = 20 * Due to the low bulk density of the applied HPMC based excipients A-C, it was not possible to manufacture a tablet with a diameter of 11 mm. New developed PVA Excipient shows improved compressibility in comparison to HPMC based excipients. 33 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

34 34 WHAT IS DOSE DUMPING?

35 What is dose dumping? Sustained release dosage forms are intended to release the drug in desired concentrations for a prolonged period of time. Therefore, they have to contain larger amounts of the drug than single-dose formulations. Dose dumping is defined as: Unintended, rapid drug release in a short period of time of the entire amount or a significant fraction of the drug contained in a modified release dosage form.* *definition based on EMA draft guideline EMA/CPMP/EWP/280/96 Corr1 Meyer, R. J. and A. S. Hussain (2005). Awareness Topic: Mitigating the Risks of Ethanol Induced Dose Dumping from Oral Sustained/Controlled Release Dosage Forms. Dose dumping is a critical topic for modified release formulations! 35 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

36 What kinds of dose dumping is possible? Inappropriate use induced dose dumping ph-induced dose dumping Alcohol-induced dose dumping tampering grinding/crushing dose division ph effect food effect dissolved in or taken with alcoholic beverages Dose dumping is a critical topic for modified release formulations! 36 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

37 37 CASE STUDY ALCOHOL INDUCED DOSE DUMP

38 Case study 1/ Topic: Test if alcohol-induced dose dumping 0% Ethanol 40% Ethanol 5% Ethanol 20% Ethanol 10% Ethanol 38 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

39 % of propranolol HCl dissolved Case study 1 No alcohol-induced dose dumping Diagram: Test alcohol dependent dissolution Legend PVA/MCC based example formulation HCl 0.1 M PVA/MCC based example formulation HCl 0.1 M / Ethanol 95 / 5 % (v/v) PVA/MCC based example formulation HCl 0.1 M / Ethanol 80 / 20 % (v/v) PVA/MCC based example formulation HCl 0.1 M / Ethanol 60 / 40 % (v/v) Time [h] USP Apparatus 2 (Paddle Apparatus), 900 ml HCl/Ethanol medium, 50 rpm, 37 C, detection wavelength 214 nm; n=3 Samples used: tablets compressed at 20 kn There is no in-vitro dose dumping effect visible over the 12-hour release time, even in a 40 % (v/v) alcohol release medium. 39 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

40 % of propranolol HCl dissolved Case study 1 No ph-dependent dose dumping Diagram: Test ph-dependent dissolution Legend Test: - HCl 0.1M - HCl ph Phosphate buffer ph 6.8 PVA Example formulation HCl 0.1 M PVA Example formulation HCl buffer ph ph shift HCl 0.1 M to phosphate buffer ph 6.8 PVA Example formulation Phosphate buffer ph 6.8 PVA Example formulation ph shift HCl 0.1 M (2h) --> Phosphate buffer ph Time [h] USP Apparatus 2 (Paddle Apparatus), 900/1000 ml medium, 50 rpm, 37 C, detection wavelength 214 nm; n=3 Samples used: tablets compressed at 20 kn Constant in-vitro release behavior is shown in different dissolution media over a broad ph range. 40 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

41 41 WRAP-UP AND SUMMARY: SUSTAINED RELEASE

42 Case studies Summary of findings High compressibility and low ejection forces over a vast range of compression forces Constant in-vitro release behavior over a broad range of compression forces and resulting tablet hardnesses No dose dumping effect in media with different alcohol content and of different ph Lubricants have no effect on the release profile but their choice may help to improve tablet hardness. Storage stability: no change of in-vitro release after 12 months of storage Lower hygroscopicity and better suitability for direct compression in comparison to HPMC based excipients Findings were confirmed with different APIs, including propranolol HCl, diltiazem HCl, theophylline, ascorbic acid, ibuprofen (not all data shown) 42 ExcipientFest 2016 Dr. Dieter Lubda - MilliporeSigma

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