Stability of Pharmaceutical Products

Rehman, Qudsia; Akash, Muhammad Sajid Hamid; Imran, Imran; Rehman, Kanwal

doi:10.1007/978-981-15-6426-0_10

Cited by 8 publications

(6 citation statements)

References 6 publications

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“…About 30 to 55% of BSA was released from the dressings within 5 h followed by a steady release of the remaining BSA in 72 h. To predict the release mechanisms of BSA from the dressings, the results were fitted to mathematical models as depicted in Table 3. The BSA release mechanism was confirmed by Korsmeyer-Peppas plots with R 2 values ranging from 0.896 to 0.971 and slope (n) < 0.5 indicating that the BSA release mechanism was governed by quasi-Fickian diffusion [48]. According to this model, as liquid penetrates the matrix the polymer chains undergo swelling and become disentangled, which is dependent on the solvent properties and the crosslinks within the matrix.…”

Section: Protein Leachingmentioning

confidence: 93%

Composite Fish Collagen-Hyaluronate Based Lyophilized Scaffolds Modified with Sodium Alginate for Potential Treatment of Chronic Wounds

Afzali

Boateng

2022

Polymers

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Chronic wounds are characterized by both decreased collagen deposition and increased collagen breakdown. It is reasonable to hypothesize that exogenous collagen can potentially promote wound healing by reducing degradation enzymes in the wound environment and disrupting the cycle of chronicity. Therefore, this study aimed to develop an optimal combination of fish collagen (FCOL), sodium alginate (SA), and hyaluronic acid (HA) loaded with bovine serum albumin (BSA) as a model protein fabricated as lyophilized scaffolds. The effects of sodium alginate (SA#) with higher mannuronic acid (M) were compared to sodium alginate (SA*) with higher guluronic acid (G). The SA* with higher G resulted in elegant scaffolds with hardness ranging from 3.74 N–4.29 N that were able to withstand the external force due to the glycosidic bonds in guluronic acid. Furthermore, the high G content also had a significant effect on the pore size, pore shape, and porosity. The water absorption (WA) ranged from 380–1382 (%) and equilibrium water content (EWC) 79–94 (%) after 24 h incubation at 37 °C. The SA* did not affect the water vapor transmission rate (WVTR) but incorporating BSA significantly increased the WVTR making these wound dressing scaffolds capable of absorbing about 50% exudate from a heavily exuding chronic wound. The protein released from the composite systems was best explained by the Korsmeyer–Peppas model with regression R2 values ranging from 0.896 to 0.971 and slope or n < 0.5 indicating that the BSA release mechanism was governed by quasi-Fickian diffusion. Cell viability assay showed that the scaffolds did not inhibit the proliferation of human dermal fibroblasts and human epidermal keratinocytes, and are therefore biocompatible. In vitro blood analysis using human whole blood confirmed that the BSA-loaded SA*:FCOL:HA scaffolds reduced the blood clotting index (BCI) by up to 20% compared to a commercially available sponge for chronic wounds. These features confirm that SA*:FCOL:HA scaffolds could be applied as a multifunctional wound dressing.

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Section: Protein Leachingmentioning

confidence: 93%

Composite Fish Collagen-Hyaluronate Based Lyophilized Scaffolds Modified with Sodium Alginate for Potential Treatment of Chronic Wounds

Afzali

Boateng

2022

Polymers

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“…CDs have numerous uses in different industrial areas, such as chemistry, pharmaceuticals, food, etc. In the pharmaceutical field, native and modified CDs have been utilized as a drug release system due to their high solubility, easy dilution, and ability to improve the physicochemical properties of the guest molecule while maintaining the conditions specified on the package, such as effectiveness and purity, for established periods [41][42][43][44][45]. Considerable improvements in active pharmaceutical ingredients (APIs) have been observed, presenting greater solubility in water, effectiveness, and physical and chemical stability [46].…”

Section: Solubility and Toxicological Considerationsmentioning

confidence: 99%

Active and Intelligent Packaging: A Review of the Possible Application of Cyclodextrins in Food Storage and Safety Indicators

Puebla-Duarte,

Santos-Sauceda,

Rodríguez-Félix

et al. 2023

Polymers

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Natural cyclodextrins (CDs) can be formed by 6, 7, or 8 glucose molecules (α-, β-, and γ-, respectively) linked in a ring, creating a cone shape. Its interior has an affinity for hydrophobic molecules, while the exterior is hydrophilic and can interact with water molecules. This feature has been used to develop active packaging applied to food, interacting with the product or its environment to improve one or more aspects of its quality or safety. It also provides monitoring information when food is optimal for consumption, as intelligent packaging is essential for the consumer and the merchant. Therefore, this review will focus on discerning which packaging is most appropriate for each situation, solubility and toxicological considerations, characterization techniques, effect on the guest properties, and other aspects related to forming the inclusion complex with bioactive molecules applied to packaging.

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“…With the help of proper storage conditions, reduction in the rate of their degradation reaction can be possible. This ensures the stability of pharmaceuticals throughout their shelf life (Rehman et al 2020;Denisov et al 2003).…”

Section: Kinetics Of Drug Degradationmentioning

confidence: 99%

Systematic strategies for degradation kinetic study of pharmaceuticals: an issue of utmost importance concerning current stability analysis practices

et al. 2022

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Degradation kinetic study ascertains the shelf life of drugs under different environmental conditions. It can facilitate the prediction of specific critical factors that can affect the quality of pharmaceuticals during storage. To date, general systematic strategies for performing degradation kinetics of drugs have not been discussed in any literature. Moreover, no regulatory guideline is available on the degradation kinetic study of pharmaceuticals. Owing to this, the kinetic behavior of drugs is not being analyzed uniformly. This article provides a detailed insight into degradation kinetic approaches including criticality in selecting different variables for the study. Factors that can affect the quality of degradation kinetic study data have been critically discussed. In addition, a systematic strategy to perform degradation kinetic study with advanced degradation models has been discussed. This article will be helpful for the researcher working in the field of stability analysis and guide to select a logical path for determining the kinetic behavior of drugs. High-quality degradation kinetic data through the properly designed study will help to establish accurate storage conditions of pharmaceuticals. This article is unique and novel of its kind and would have a significant contribution to the field of stability analysis.

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Stability of Pharmaceutical Products

Cited by 8 publications

References 6 publications

Composite Fish Collagen-Hyaluronate Based Lyophilized Scaffolds Modified with Sodium Alginate for Potential Treatment of Chronic Wounds

Composite Fish Collagen-Hyaluronate Based Lyophilized Scaffolds Modified with Sodium Alginate for Potential Treatment of Chronic Wounds

Active and Intelligent Packaging: A Review of the Possible Application of Cyclodextrins in Food Storage and Safety Indicators

Systematic strategies for degradation kinetic study of pharmaceuticals: an issue of utmost importance concerning current stability analysis practices

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