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Pharmaceutics
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Stability of Medicines and Novel Approaches for Predicting Drug Stability
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Stability of Medicines and Novel Approaches for Predicting Drug Stability

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".

Deadline for manuscript submissions: 20 May 2025 | Viewed by 44209

Special Issue Editors

Dr. Dolores R. Serrano

E-Mail Website1 Website2
Guest Editor
Departament of Pharmaceutics and Food Technology, School of Pharmacy, University Complutense, Avenida Complutense, 28040 Madrid, Spain
Interests: nanomedicines; microparticles; sustained-release formulations; liposomes; nanoparticles; drug targeting; pharmacokinetics
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Juan José Torrado Durán

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Co-Guest Editor
Pharmaceutics and Food Technology, School of Pharmacy, Complutense University of Madrid, Madrid, Spain
Interests: conventional pharmaceutical dosage forms (tablets, capsules, semisolid and liquid formulations); new controlled release systems (pellets, nanoparticles, microcapsules, microspheres and liposomes) including production and quality control
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Stability is a key parameter to consider when preparing pharmaceutical dosage forms. Novel drug delivery systems have been shown to enhance both the chemical and physical stability of drugs, which is of extreme importance in the pharmaceutical industry. Advanced manufacturing techniques such as 3D printing have arisen as a promising technology to prepare extemporaneous compounding formulations. However, stability studies on these formulations are limited and represent a topic worthy of investigation. This Special Issue is focused on understanding the impact of novel drug delivery systems and new drug manufacturing methods on final drug stability. In addition, stability testing using novel methodological approaches such as accelerated predictive stability (APS) or accelerated stability assessment programs (ASAP) will be covered in this issue as an alternative to conventional ICH guidelines, as there is currently little information available regarding prediction of physical stability of amorphous systems as well as biological compounds such as peptides and proteins.

Dr. Dolores R. Serrano
Prof. Dr. Juan José Torrado Durán
Guest Editors

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Keywords

  • stability
  • 3D printing
  • ICH
  • physical stability
  • biologicals

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Published Papers (10 papers)

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Research

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17 pages, 2130 KiB  
Article
Accelerated Predictive Stability Testing: Accelerating Registration Phase and Application of Reduced Designs for Shelf-Life Determination of Parenteral Drug Product
by Lara Pavčnik, Mateja Prunk, Tina Trdan Lušin and Robert Roškar
Pharmaceutics 2025, 17(2), 160; https://doi.org/10.3390/pharmaceutics17020160 - 25 Jan 2025
Viewed by 945
Abstract
Objectives: This article explores the applicability of the accelerated stability assessment program (ASAP) in stability studies for parenteral medications. Conventional stability testing requires extensive evaluation over the entire shelf life of a product, which can be very time-consuming. In contrast, ASAP provides an [...] Read more.
Objectives: This article explores the applicability of the accelerated stability assessment program (ASAP) in stability studies for parenteral medications. Conventional stability testing requires extensive evaluation over the entire shelf life of a product, which can be very time-consuming. In contrast, ASAP provides an efficient approach to support drug product development and expedite regulatory procedures. Methods: The study involved subjecting the medication to different stress and long-term stability conditions and monitoring the formation of degradation products. A systematic methodology was employed to evaluate the stress stability data of the parenteral medication using various designs (full and reduced). ASAP models were then developed from these data and assessed using the statistical parameters R2 (coefficient of determination) and Q2 (predictive relevance). To validate the accuracy of the models, the predicted levels of degradation products from each of the 13 models were compared with the actual long-term stability results using the relative difference parameter. Results: The results confirmed the suitability of the evaluated full model and 11 reduced models for predicting degradation products, except for the two-temperature model, demonstrating the effectiveness of ASAP in stability studies and providing reliable predictions. However, the three-temperature model was identified as the most appropriate model for the parenteral medication under investigation. The statistical analyses showed high R2 and Q2 values, indicating robust model performance and predictive accuracy. Consequently, we applied the selected model on various formulations, demonstrating the suitability of the model and impurity levels below the ICH specification limit. Conclusions: This research enhances understanding of how ASAP designs can be applied to stability studies for parenteral medications and demonstrates the significance of the application of ASAP during drug product development to expedite the initiation of procedures and implement post-approval variations. Full article
(This article belongs to the Special Issue Stability of Medicines and Novel Approaches for Predicting Drug Stability)
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13 pages, 1779 KiB  
Article
Assessing Drug Product Shelf Life Using the Accelerated Stability Assessment Program: A Case Study of a GLPG4399 Capsule Formulation
by Dattatray Modhave, Sara Vrielynck and Kevin Roeleveld
Pharmaceutics 2024, 16(11), 1400; https://doi.org/10.3390/pharmaceutics16111400 - 30 Oct 2024
Viewed by 1899
Abstract
Objective: To evaluate and project the shelf life of GLPG4399, an early-phase clinical drug formulation by applying the Accelerated Stability Assessment Program (ASAP) approach. Methods: Forced degradation conditions were implemented to identify the stability-limiting degradation product. The drug and its degradation products were [...] Read more.
Objective: To evaluate and project the shelf life of GLPG4399, an early-phase clinical drug formulation by applying the Accelerated Stability Assessment Program (ASAP) approach. Methods: Forced degradation conditions were implemented to identify the stability-limiting degradation product. The drug and its degradation products were separated using a validated liquid chromatography method. Then, the selected clinical capsule formulation was placed in a glass vial and exposed to accelerated short-term conditions of combinations of high- and low-level heat and humidity in an open state for 5 weeks. The liquid chromatography results were evaluated using the ASAP, which is based on the moisture-modified Arrhenius principle. The resulting data were fitted using a suitable diffusion kinetics method. Results: The developed model was applied to predict the shelf life of the drug product when using clinically appropriate primary packaging (high-density polyethylene container). The derived stability parameters of the moisture-modified Arrhenius equation were the Arrhenius collision frequency, activation energy, and humidity sensitivity constant. The goodness of fit parameters R2 (>0.95) and goodness of prediction Q2 (>0.80) parameters for the selected model were acceptable. The results of the accelerated, short-term stability study were verified against real-time, long-term 12-month data. Conclusions: We demonstrated the application of the ASAP approach to evaluate the shelf life of a GLPG4399 solid capsule formulation. The studied ASAP approach can be extended to evaluate the stability and shelf-life estimations of other early-phase clinical formulations. Full article
(This article belongs to the Special Issue Stability of Medicines and Novel Approaches for Predicting Drug Stability)
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12 pages, 698 KiB  
Article
Matrixing Designs for Shelf-Life Determination of Parenteral Drug Product: A Comparative Analysis of Full and Reduced Stability Testing Design
by Lara Pavčnik, Igor Locatelli, Tina Trdan Lušin and Robert Roškar
Pharmaceutics 2024, 16(9), 1117; https://doi.org/10.3390/pharmaceutics16091117 - 24 Aug 2024
Cited by 1 | Viewed by 1387
Abstract
This article highlights the applicability of matrixing designs in stability studies for parenteral medications. The traditional approach involves extensive testing over the product’s shelf-life. However, matrixing designs offer an alternative approach where only a fraction of samples is tested at each time point. [...] Read more.
This article highlights the applicability of matrixing designs in stability studies for parenteral medications. The traditional approach involves extensive testing over the product’s shelf-life. However, matrixing designs offer an alternative approach where only a fraction of samples is tested at each time point. The study conducted in this article focused on three parenteral medications and examined stability data under long-term condition. Degradation products were identified as critical parameter, and kinetics of degradation varied among the selected products. A systematic methodology was adopted to evaluate the data using different matrixing designs. The regression models obtained were assessed using statistical parameters S and R2. Also, each of the 28 matrixing designs were compared to the full design with statistical parameter RMSE and the shelf-life. The results confirmed that each of the evaluated matrixing designs can be applied, whether degradation product shows a linear or non-linear increase, and demonstrated that a reduction of two time points per batch is the most appropriate. In conclusion, this research contributes to the understanding of utilizing reduced matrixing designs in stability studies for parenteral medications and can be an effective strategy to reduce costs and time of stability testing while maintaining the necessary level of precision and reliability. Full article
(This article belongs to the Special Issue Stability of Medicines and Novel Approaches for Predicting Drug Stability)
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16 pages, 4694 KiB  
Article
Physicochemical Stability of Hospital Parenteral Nutrition Solutions: Effect of Changes in Composition and Storage Protocol
by Luis Otero-Millán, Brais Bea-Mascato, Jose Luis Legido Soto, Noemi Martínez-López-De-Castro and Natividad Lago-Rivero
Pharmaceutics 2024, 16(5), 572; https://doi.org/10.3390/pharmaceutics16050572 - 23 Apr 2024
Cited by 2 | Viewed by 1987
Abstract
(1) Background: Parenteral nutrition (PN) is a technique used for the administration of nutrients to patients for whom traditional routes cannot be used. It is performed using solutions with extremely complex compositions, which can give rise to a large number of interactions. These [...] Read more.
(1) Background: Parenteral nutrition (PN) is a technique used for the administration of nutrients to patients for whom traditional routes cannot be used. It is performed using solutions with extremely complex compositions, which can give rise to a large number of interactions. These interactions can impact their stability and put the patient’s life at risk. The aim of this study is to determine how changes in composition and storage protocol affect the stability of NP solutions. (2) Methods: Twenty-three samples were prepared according to routine clinical practice, with modifications to the concentration of some components. The samples were stored at room temperature (RT) and refrigerated (4 °C). Measurements of the droplet diameter, pH, density and viscosity were performed for both storage protocols on days 1, 3, 10 and 14. (3) Results: The samples with the lowest concentration of lipids (PN13-17) and proteins (PN18-22) showed a larger droplet diameter than the rest of the samples throughout the experiments. The USP limits were exceeded for some of the measurements of these sample groups. The pH density and viscosity remained relatively constant under the conditions studied. (4) Conclusions: The PN samples were considered stable and safe for administration under real-world conditions, but the samples with the lowest concentrations of lipids and proteins showed a tendency towards emulsion instability. Full article
(This article belongs to the Special Issue Stability of Medicines and Novel Approaches for Predicting Drug Stability)
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19 pages, 3783 KiB  
Article
Investigation of the Impact of Saccharides on the Relative Activity of Trypsin and Catalase after Droplet and Spray Drying
by Johanna Dieplinger, Christina Moser, Gerhard König, Joana T. Pinto and Amrit Paudel
Pharmaceutics 2023, 15(10), 2504; https://doi.org/10.3390/pharmaceutics15102504 - 21 Oct 2023
Cited by 1 | Viewed by 1788
Abstract
While using saccharides as stabilizers for therapeutic protein drying is common, the mechanisms underlying the stabilization during drying remain largely unexplored. Herein, we investigated the effect of different saccharides, trehalose dihydrate (TD), dextran (DEX), and hydroxypropyl β-cyclodextrins (low substitution—HP and high substitution—HPB), on [...] Read more.
While using saccharides as stabilizers for therapeutic protein drying is common, the mechanisms underlying the stabilization during drying remain largely unexplored. Herein, we investigated the effect of different saccharides, trehalose dihydrate (TD), dextran (DEX), and hydroxypropyl β-cyclodextrins (low substitution—HP and high substitution—HPB), on the relative activities of the enzymes trypsin and catalase during miniaturized drying (MD) or spray drying (SD). For trypsin, the presence of saccharides, especially HP, was beneficial, as it significantly improved the enzyme activity following MD. The HPB preserved trypsin’s activity during MD and SD. Adding saccharides during MD did not show a notable improvement in catalase activities. Increasing TD was beneficial during the SD of catalase, as indicated by significantly increased activity. Molecular docking and molecular dynamics simulations oftrypsin with HP or HPB revealed the influence of their substitution on the binding affinity for the enzyme. A higher affinity of HP to bind trypsin and itself was observed during simulations. Experimentally, activity reduction was mainly observed during MD, attributable to the higher droplet temperature during MD than during SD. The activities from the experiments and aggregation propensity from molecular modeling helped elucidate the impact of the size of protein and saccharides on preserving the activity during drying. Full article
(This article belongs to the Special Issue Stability of Medicines and Novel Approaches for Predicting Drug Stability)
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16 pages, 3155 KiB  
Article
Preformulation and Long-Term Stability Studies of an Optimized Palatable Praziquantel Ethanol-Free Solution for Pediatric Delivery
by Giselle Bedogni, Paula Garcia, Katia Seremeta, Nora Okulik and Claudio Salomon
Pharmaceutics 2023, 15(8), 2050; https://doi.org/10.3390/pharmaceutics15082050 - 30 Jul 2023
Cited by 3 | Viewed by 3137
Abstract
To date, the treatment for cysticercosis and neurocysticercosis consists of a single oral intake of praziquantel (5–10 mg/kg), which since it is only available as tablets, hinders its administration to pediatric patients. Praziquantel is a poorly water-soluble drug which represents a challenge for [...] Read more.
To date, the treatment for cysticercosis and neurocysticercosis consists of a single oral intake of praziquantel (5–10 mg/kg), which since it is only available as tablets, hinders its administration to pediatric patients. Praziquantel is a poorly water-soluble drug which represents a challenge for its formulation in solution, particularly for the pediatric population. Thus, this study aimed to develop a palatable solution for praziquantel using pharmaceutical-accepted co-solvent systems. A design of experiments approach was applied to identify the optimal conditions for achieving a suitable amount of praziquantel in solution using co-solvent mixtures. Thus, praziquantel solubility increased from 0.38 up to 43.50 mg/mL in the optimized system. A taste masking assay in healthy human volunteers confirmed a successful reduction of drug bitterness after the addition of selected flavors and a sweetener. Stability studies were also conducted at different temperatures (4, 25, and 40 °C) for 12 months Even though the presence of the three known impurities of praziquantel was observed, their amounts never exceeded the acceptance criteria of the USP. Thus, this novel approach should be considered a valuable alternative for further preclinical studies considering the high prevalence of this infection worldwide. Full article
(This article belongs to the Special Issue Stability of Medicines and Novel Approaches for Predicting Drug Stability)
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12 pages, 1589 KiB  
Article
Guiding Clinical Prescription of Topical Extemporaneous Formulations of Sodium Cromoglycate Based on Pharmaceutical Performance
by Olga González-González, Enrique Leal, Mercedes Martín-Martínez, Liliana Bautista, Maria Paloma Ballesteros, Juan J. Torrado and Dolores R. Serrano
Pharmaceutics 2023, 15(6), 1609; https://doi.org/10.3390/pharmaceutics15061609 - 29 May 2023
Cited by 2 | Viewed by 3264
Abstract
Cromoglycate (SCG) is widely used for allergy processes, and inflammatory states acting as a mast cell membrane stabilizer that inhibits the histamine and mediator release. Currently, SCG topical extemporaneous compounding formulations are prepared in hospitals and community pharmacies, as no industrial fabricated medicines [...] Read more.
Cromoglycate (SCG) is widely used for allergy processes, and inflammatory states acting as a mast cell membrane stabilizer that inhibits the histamine and mediator release. Currently, SCG topical extemporaneous compounding formulations are prepared in hospitals and community pharmacies, as no industrial fabricated medicines are available in Spain. The stability of these formulations is unknown. Additionally, there are no clear guidelines on which concentration and vehicle are more suitable to enhance permeation across the skin. In this work, the stability of commonly prescribed topical SCG formulations in clinical practice was evaluated. Different vehicles commonly employed by pharmacists daily for formulating topical SCG were investigated (Eucerinum, Acofar Creamgel, and Beeler’s base) at different concentrations, ranging from 0.2 to 2%. The stability of topical extemporaneous compounded SCG formulations can be extended for up to three months at room temperature (25 °C). Creamgel 2% formulations significantly improved the topical permeation of SCG across the skin, being 4.5-fold higher than formulations prepared with Beeler’s base. The reason attributed to this performance can be related to the lower droplet size formed upon dilution in aqueous media combined with a lower viscosity, which facilitates its application and extensibility on the skin. The higher the SCG concentration in Creamgel formulations, the higher the permeability across both synthetic membranes and pig skin (p-value < 0.05). These preliminary results can be used as a guide to prompt a rational prescription of topical SCG formulations. Full article
(This article belongs to the Special Issue Stability of Medicines and Novel Approaches for Predicting Drug Stability)
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16 pages, 10007 KiB  
Article
Effect of Primary Packaging Material on the Stability Characteristics of Diazepam and Midazolam Parenteral Formulations
by María José Rodríguez Fernández, Dolores Remedios Serrano Lopez and Juan José Torrado
Pharmaceutics 2022, 14(10), 2061; https://doi.org/10.3390/pharmaceutics14102061 - 27 Sep 2022
Cited by 6 | Viewed by 4875
Abstract
Diazepam and midazolam are formulated in autoinjectors for parenteral administration to decrease seizures in the case of emergency. However, the compatibility of these lipophilic drugs with the primary packaging material is a key part of drug formulation development. In this work, diazepam and [...] Read more.
Diazepam and midazolam are formulated in autoinjectors for parenteral administration to decrease seizures in the case of emergency. However, the compatibility of these lipophilic drugs with the primary packaging material is a key part of drug formulation development. In this work, diazepam and midazolam were packaged in glass syringes as parenteral solutions using two different elastomeric sealing materials (PH 701/50 C BLACK and 4023/50 GRAY). Syringes were stored at three different storage temperatures: 4, 25, and 40 °C. At different time points over 3 years, physical appearance, benzodiazepine sorption on the sealing elastomeric materials, and drug content in solution were assayed. A detailed study on the adsorption profile of both benzodiazepines on the elastomeric gaskets was performed, indicating that the novel rubber material made of bromobutyl derivatives (4023/50 GRAY) is a better choice for manufacturing autoinjectors due to lower drug adsorption. Diazepam showed a better stability profile than midazolam, with the latter solubilised as a hydrochloride salt in an acidic pH that can affect the integrity of the elastomer over time. The amount of drug adsorbed on the surface of the elastomer was measured by NIR and correlated using chemometric models with the amount retained in the elastomeric gaskets quantified by HPLC. Full article
(This article belongs to the Special Issue Stability of Medicines and Novel Approaches for Predicting Drug Stability)
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Review

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26 pages, 5592 KiB  
Review
Co-Crystallization Approach to Enhance the Stability of Moisture-Sensitive Drugs
by Madhukiran R. Dhondale, Pradip Thakor, Amritha G. Nambiar, Maan Singh, Ashish K. Agrawal, Nalini R. Shastri and Dinesh Kumar
Pharmaceutics 2023, 15(1), 189; https://doi.org/10.3390/pharmaceutics15010189 - 5 Jan 2023
Cited by 25 | Viewed by 7087
Abstract
Stability is an essential quality attribute of any pharmaceutical formulation. Poor stability can change the color and physical appearance of a drug, directly impacting the patient’s perception. Unstable drug products may also face loss of active pharmaceutical ingredients (APIs) and degradation, making the [...] Read more.
Stability is an essential quality attribute of any pharmaceutical formulation. Poor stability can change the color and physical appearance of a drug, directly impacting the patient’s perception. Unstable drug products may also face loss of active pharmaceutical ingredients (APIs) and degradation, making the medicine ineffective and toxic. Moisture content is known to be the leading cause of the degradation of nearly 50% of medicinal products, leading to impurities in solid dose formulations. The polarity of the atoms in an API and the surface chemistry of API particles majorly influence the affinity towards water molecules. Moisture induces chemical reactions, including free water that has also been identified as an important factor in determining drug product stability. Among the various approaches, crystal engineering and specifically co-crystals, have a proven ability to increase the stability of moisture-sensitive APIs. Other approaches, such as changing the salt form, can lead to solubility issues, thus making the co-crystal approach more suited to enhancing hygroscopic stability. There are many reported studies where co-crystals have exhibited reduced hygroscopicity compared to pure API, thereby improving the product’s stability. In this review, the authors focus on recent updates and trends in these studies related to improving the hygroscopic stability of compounds, discuss the reasons behind the enhanced stability, and briefly discuss the screening of co-formers for moisture-sensitive drugs. Full article
(This article belongs to the Special Issue Stability of Medicines and Novel Approaches for Predicting Drug Stability)
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21 pages, 4816 KiB  
Review
Drug Stability: ICH versus Accelerated Predictive Stability Studies
by Olga González-González, Irving O. Ramirez, Bianca I. Ramirez, Peter O’Connell, Maria Paloma Ballesteros, Juan José Torrado and Dolores R. Serrano
Pharmaceutics 2022, 14(11), 2324; https://doi.org/10.3390/pharmaceutics14112324 - 28 Oct 2022
Cited by 86 | Viewed by 15051
Abstract
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), along with the World Health Organization (WHO), has provided a set of guidelines (ICH Q1A-E, Q3A-B, Q5C, Q6A-B) intended to unify the standards for the European Union, Japan, and [...] Read more.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), along with the World Health Organization (WHO), has provided a set of guidelines (ICH Q1A-E, Q3A-B, Q5C, Q6A-B) intended to unify the standards for the European Union, Japan, and the United States to facilitate the mutual acceptance of stability data that are sufficient for registration by the regulatory authorities in these jurisdictions. Overall, ICH stability studies involve a drug substance tested under storage conditions and assess its thermal stability and sensitivity to moisture. The long-term testing should be performed over a minimum of 12 months at 25 °C ± 2 °C/60% RH ± 5% RH or at 30 °C ± 2 °C/65% RH ± 5% RH. The intermediate and accelerated testing should cover a minimum of 6 months at 30 °C ± 2 °C/65% RH ± 5% RH (which is not necessary if this condition was utilized as a long-term one) and 40 °C ± 2 °C/75% RH ± 5% RH, respectively. Hence, the ICH stability testing for industrially fabricated medicines is rigorous and tedious and involves a long period of time to obtain preclinical stability data. For this reason, Accelerated Predictive Stability (APS) studies, carried out over a 3–4-week period and combining extreme temperatures and RH conditions (40–90 °C)/10–90% RH, have emerged as novel approaches to predict the long-term stability of pharmaceutical products in a more efficient and less time-consuming manner. In this work, the conventional ICH stability studies versus the APS approach will be reviewed, highlighting the advantages and disadvantages of both strategies. Furthermore, a comparison of the stability requirements for the commercialization of industrially fabricated medicines versus extemporaneous compounding formulations will be discussed. Full article
(This article belongs to the Special Issue Stability of Medicines and Novel Approaches for Predicting Drug Stability)
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