New Horizons in Accelerated Stability Modeling-- Tablet Dissolution, Tablet Disintegration and Product Appearance
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1 New Horizons in Accelerated Stability Modeling-- Tablet Dissolution, Tablet Disintegration and Product Appearance Kenneth C. Waterman, Ph.D. FreeThink Technologies, Inc. Branford, CT
2 Part I: Accelerated Dissolution Stability Determination Can dissolution changes with time be modeled in an accelerated process?
3 Solid Dosage Forms 1.Immediate release tablets 2.Capsules 3.Controlled release tablets a.hydrophilic matrix tablets b.coated beads
4 Solid Dosage Forms 1.Immediate release tablets 2.Capsules 3.Controlled release tablets a.hydrophilic matrix tablets b.coated beads
5 Dissolution Testing Stage 1: 6 tablets tested, all >Q+5% Stage 2: additional 6 tablets tested; average (of 12) > Q; all tablets >Q-15% Stage 3: 12 more tablets tested; average (of 24) >Q; <3 tablets have <Q-15%; 0 tablets <Q-25% ken.waterman@freethinktech.com
6 Notes About Stage 1 and Variability Many Stage 1 dissolution failures observed on stability studies Very few Stage 2 dissolution failures observed Stage 1 dissolution requires all 6 tablets have Q+5 If potency of lot is low, content uniformity leads to random failures (predictably) If any loss of potency, makes matters worse (predictably) Variability much less likely to cause Stage 2 failure Stage 1 failures on stability often investigated, yet not reflective of any dissolution instability! ken.waterman@freethinktech.com
7 Notes About Stage 1 and Variability Example: Q = 75% (at time t) Tablet dissolution variability (content uniformity + measurement variability) = 5% Average amount dissolved at t = 95% (for lot with 100% potency) Example lot potency (average) = 97% Probability of failing Stage 1: 4.4% Probability of failing Stage 2: <0.001% ken.waterman@freethinktech.com
8 Critical Relative Humidity (CRH) Entropy high Entropy low
9 Critical Relative Humidity (CRH) Entropy increases Dissolved solute increases entropy: decreases advantage of going into vapor phase. Result: saturated vapor pressure in air reduced
10 Critical Relative Humidity (CRH) Saturated solution (i.e., when solid present at equilibrium with its solution) has a single activity (entropy and enthalpy) Air above has a single partial pressure of water (saturated, but lower than that above pure water) ken.waterman@freethinktech.com
11 Critical Relative Humidity (CRH) If more water added, more solute dissolves, but concentration remains saturated therefore vapor pressure remains saturated
12 Critical Relative Humidity (CRH) If solid placed in air at RH > CRH, condensation (deliquescence) will occur since above water s saturation partial pressure (though not above that over pure water) Deliquescence is not absorption: liquid water is condensed from the air CRH is a sharp point: below this RH, not saturated so no condensation occurs Ability to lower the partial pressure of saturated air depends on ability to raise entropy of liquid water solution Only depends on moles of species in solution Will change with temperature if saturated solubility changes Note, most compounds increase solubility as a function of temperature ken.waterman@freethinktech.com
13 Critical Relative Humidity (CRH) and Dissolution Many tablets will dramatically change dissolution after deliquescence Packaging and storage conditions will predict when this abrupt transition occurs Can use ASAPprime to determine shelf-life: time before deliquescence occurs
14 Example Issue NaCl 75%RH (40 C) Sorbitol 69%RH (40 C) Fructose 64%RH (40 C)
15 Note Some polymers behave like deliquescing materials even when not technically dissolving: sections of the polymer dissolve to alter water s entropy and lower CRH Example: croscarmellose sodium ken.waterman@freethinktech.com
16 Immediate Release Tablet Dissolution Stability when Storage <CRH Step 1: Critical Relative Humidity (CRH) Screen Screen for deliquescence point (CRH) from C Accelerated dissolution stability studies need to stay below CRH ken.waterman@freethinktech.com
17 Disso Stability Design for Drug Product I deliquescence RH T ( C) ken.waterman@freethinktech.com
18 General Behavior 15 min %dissolved C 50 C 60 C 70 C Specification limit Time (days) Dissolution behavior for Drug Product I at 15-min as a function of time at specified temperatures (80%RH) ken.waterman@freethinktech.com
19 Drug Product I: General Behavior Change in disso not gradual: discontinuous function Cannot assign a rate of change Can still assign a storage time to failure Note: potency not changed significantly during any of the challenge conditions ken.waterman@freethinktech.com
20 Dissolution Stability: Product 1 Shows both temperature and RH dependencies of storage time to fail Can fit with ASAPprime modified Arrhenius equation: ln 1 t failure = lna E a RT + B(RH) ken.waterman@freethinktech.com
21 Error Bars Can assign maximum and minimum storage times to failure at each condition Assign an approximate average and standard deviation to each failure time Default to 50%RSD
22 Drug Product I Time to Dissolution Failure Residuals ln A = E a = kcal/mol B = R 2 = Q 2 = ken.waterman@freethinktech.com
23 Observations ASAPprime fitting model consistent with observed data Remarkable that Arrhenius-type description can be used here (with the isoconversion concept) May indicate that the change in dissolution involves motion having a barrier (impacted by activation temperature; and mobility RH) ken.waterman@freethinktech.com
24 Very High B Term Observed B terms for chemical stability usually range from B term for product 1 dissolution stability = 0.24 Means small change in RH will lead to large change in stability Can be mistaken for a threshold or critical RH: in fact, appears continuous ken.waterman@freethinktech.com
25 Dissolution vs. Disintegration Product I 20 y = x R² = Days to dissolution failure Days to disintegration failure ken.waterman@freethinktech.com
26 Drug Product I Time to Disintegration Failure Residuals ken.waterman@freethinktech.com
27 Dissolution vs. Disintegration Product I Dissolution and disintegration storage times to failure linearly correlated Implies that the change in dissolution directly linked to change in disintegration Slope >1 (failure more readily seen for disintegration) Hypothesis: higher shear in disso test requires greater changes in tablet before observable ken.waterman@freethinktech.com
28 Tablet 1 Dissolution/Disintegration Stability Disintegrant in Tablet 1 is croscarmellose sodium Reportedly works by wicking plus swelling Wicking weakens interparticle forces Swelling provide shear to break up tablet Does aging reduce wicking, swelling or affect the interparticle interactions themselves? Research ongoing ken.waterman@freethinktech.com
29 Drug Product 2 Design RH Temperature ( C) ken.waterman@freethinktech.com
30 Product 2 Tablet Dissolution Change in disso again discontinuous Can again assign storage times to dissolution failure ken.waterman@freethinktech.com
31 ln A = E a = kcal/mol B = R 2 = Tablet 2 Storage Time to Dissolution Failure Residual Graphs ken.waterman@freethinktech.com
32 Very High B Term Observed B terms for chemical stability usually range from B term for Product 2 dissolution stability = 0.13 Means small change in RH will lead to large change in stability Can be mistaken for a threshold or critical RH: in fact, appears continuous ken.waterman@freethinktech.com
33 Dissolution vs. Disintegration Product 2 Days to dissolution failure y = x R² = Days to disintegration failure ken.waterman@freethinktech.com
34 Dissolution vs. Disintegration Product 2 Dissolution and disintegration storage times to fail linearly correlated Implies that the change in dissolution directly linked to change in disintegration Slope >1 (failure more readily seen for disintegration) Hypothesis: higher shear in disso test requires greater changes in tablet before observable ken.waterman@freethinktech.com
35 Tablet 2 Dissolution/Disintegration Stability Disintegrant in Tablet 1 is sodium starch glycolate Reportedly works by swelling Swelling provide shear to break up tablet Does aging reduce swelling or affect the interparticle interactions themselves? Research ongoing ken.waterman@freethinktech.com
36 Solid Dosage Forms 1.Immediate release tablets 2.Capsules 3.Controlled release tablets a.hydrophilic matrix tablets b.coated beads
37 Hydrophilic Matrix Controlled Release Tablets Viscous gel formed from high molecular weight, water soluble polymer Drug release controlled by combination of erosion + slowed drug diffusion As ages, MW reduces (polymer strand degradation) This chemical process follows ASAPprime model Results in faster drug release upon aging, which can be modeled effectively ken.waterman@freethinktech.com
38 Appearance Stability In some cases, shelf-life is limited by changes in the appearance of a product For tablets different factors: Color Mottle Cracking, etc. ken.waterman@freethinktech.com
39 Appearance Stability In some cases, shelf-life is limited by changes in the appearance of a product For tablets different factors: Color Mottle Cracking, etc. ken.waterman@freethinktech.com
40 Tablet Color Stability Root causes Chemical degradation Migration Can we model these in accelerated process?
41 Tablet Color Stability 1. Need analytical method 2. Need specification limit
42 Quantifying Color Tristimulus L,a,b color space 42
43 Color Quantification Tristimulus measurements allow for good quantification of tablet color using commercial equipment Need custom holder for each sample
44 Setting Specifications Often done qualitatively Switch to quantitative (line up tablets) Assigned specification Greater aging
45 Product Behavior 60 cc-hdpe bottle 30 tablets with 200 mg MCC mg spray-dried lactose ASAPprime using diffusion modeling 25 C/60%RH ken.waterman@freethinktech.com
46 Product Behavior 60 cc-hdpe bottle 30 tablets with 200 mg MCC mg spray-dried lactose ASAPprime using diffusion modeling 30 C/75%RH ken.waterman@freethinktech.com
47 Product Behavior 60 cc-hdpe bottle 30 tablets with 200 mg MCC mg spray-dried lactose ASAPprime using diffusion modeling Add 0.5 g silica gel desiccant 30 C/75%RH ken.waterman@freethinktech.com
48 New Horizons Summary For IR tablets, current data support Storage time-to-failure approach validity Storage failure times accelerated by both T + RH in continuous manner (no T/RH cross-term): follows modified Arrhenius equation of ASAPprime Use of disintegration vs. dissolution testing For hydrophilic matrix CR tablets, can use ASAPprime since loss of control a chemical process Can underwrite disso stability with short-term studies ASAPprime can be applied to color changes Need to use tristimulus measurements Need to establish specification limits ken.waterman@freethinktech.com
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