A Review on Stability Testing Guidelines of Pharmaceutical Products

Zothanpuii, F; Rekapalli, Rajesh; Selvakumar, K

doi:10.22159/ajpcr.2020.v13i10.38848

Cited by 9 publications

(4 citation statements)

References 15 publications

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“…Physical stability was observes physical changes in preparation such as organoleptic examination, pH, homogeneity, specific gravity, and changes in nanoemulsion characteristics. Physical stability can be reviewed by comparing the physical properties of the preparation before and after the centrifugation test, thermal cycling, and real-time methods (Zothanpuii et al, 2020) .…”

Section: Discussionmentioning

confidence: 99%

Characteristics and Physical Stability of Nanoemulsion as a Vehicle for Anti-Aging Cosmetics: A Systematic Review

Rachman

Soeratri

2023

JFIKI

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Background: Skin aging can be overcome by applying anti-aging cosmetics. Many active ingredients that have anti-aging potential are derived from plants, and these materials must be delivered with a sound skin delivery system, namely nanoemulsion. The characteristics of nanoemulsion are closely related to physical stability. Objective: This study aims to conduct a systematic review of in vivo and in vitro study designs to examine the characteristics and physical stability of nanoemulsions used in topical anti-aging cosmetics. Methods: A systematic literature review based on the PRISMA statement was used to review the articles regarding nanoemulsions’ characteristics and physical stability. The article search was accessed from an internet search database: Scopus, Pubmed, and Web of Science, published between January 2012 and June 2022. Results: Of the 244 articles, 44 were found to be related to the characteristics and physical stability of nanoemulsions in anti-aging cosmetics. These showed that active ingredients with antioxidant activity, filter UV rays, moisturizing agents, and cell-repairing agents are delivered by a nanoemulsion system with various types and ratios of surfactants, cosurfactants, and oil phases. Tween 80, Span 80, Transcutol HP, and Caprylic/capric triglyceride are the most widely used nanoemulsion compositions. Conclusion: The type and composition of the oil phase, surfactant, and cosurfactant affect the characteristics of the nanoemulsion (droplet size, polydispersity index, viscosity, zeta potential) and the physical stability of the nanoemulsion so that it can deliver active ingredients that have the potential as anti-aging well.

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Section: Discussionmentioning

confidence: 99%

Characteristics and Physical Stability of Nanoemulsion as a Vehicle for Anti-Aging Cosmetics: A Systematic Review

Rachman

Soeratri

2023

JFIKI

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“…The official tests were performed according to the standard specifications of the United State Pharmacopoeia 2020 (USP43-NF35). Other non-official tests, including the hardness, friability, and disintegration tests, were performed as described by Ramu et al, 2014 and Ali et al [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18] Physical Appearance For the detection of any change in the physical appearance, a direct comparison between tablets before and after storage was made. This comparison includes tablet color, odor, thickness, texture quality, and any change in shape.…”

Section: Methodsmentioning

confidence: 99%

“…2 Accordingly, the quality of the product must be maintained during manufacturing, transportation, and storage, as well as during handling by patients. 5 Any pharmaceutical product was subjected to numerous studies before it is ready for human use, including the stability study and expiration date. Drug stability is defined as "the ability of a drug substance or medicinal product to remain within definite specifications to maintain its quality and efficacy throughout the validity period".…”

mentioning

confidence: 99%

Eff ects of Non-standard Storage Conditions on the Stability, Safety and Suitability of Drug Consumption

Alsammarraie¹,

Mahdi²

2023

IJPQA

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Drugs are distinctive and sensitive products. It should pass specifi c tests and have specifi c criteria for human use. The disparity of any of the acceptance criteria will infl uence the product’s eff ectiveness, despite the product being still in validated expiry date. The stability study and manufacturing of many drugs were done at specifi c climatic zones, but marketed and sold at diff erent climatic zones. In a hot poor country or country that suff ers from a power supply shortage (like in Iraq), it is impossible to provide standard storage conditions as the manufacturer recommends. The research aims to study the eff ects of nonstandard storage conditions on the offi cial and non-offi cial acceptance criteria for stored tablets compared to the same newly manufactured tablets. The results showed that the physical appearance, tablet hardness, friability, disintegration, uniformity of weight, assay was not aff ected. On the other hand, the dissolution profi le of the stored products showed a change in the solubility behavior. From the results, we can conclude that storage conditions may not aff ect the content of the active substance. Still, it may aff ect other characteristics of the active substance, such as solubility. The research recommends the necessity of scrutiny of the storage conditions of drugs and not being lenient with them. Also recommends the necessity to study the dissolution profi le and stability of excipients when conducting a drug stability study and determining the expiry date.

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“…Physical stability studies of optimized formulations of control release bilayer floating effervescent (F2) and noneffervescent tablets (F5) were carried out according to International Conference on Harmonization (ICH) guidelines [40]. Our optimized batches were sealed in an airtight aluminum package and kept in a humidity chamber.…”

Section: Stability Studymentioning

confidence: 99%

Controlled Release Bilayer Floating Effervescent and Noneffervescent Tablets Containing Levofloxacin and Famotidine

Tufail,

Shah,

Khan

et al. 2024

International Journal of Polymer Science

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The present study is aimed at designing bilayer-floating tablets to improve the drug concentration in the stomach for enhanced therapeutic efficacy. The tablets are comprised of an upper layer of levofloxacin (466.5 mg) and a lower layer of famotidine (133.5 mg). Five formulations (F1-F5) were developed by using hydroxypropyl methylcellulose grades (K4M, K15M, and K100M) along with Carbopol 934. In the case of the effervescent system (F1-F3), sodium bicarbonate was added to impart buoyancy to the tablets; while in the case of noneffervescent formulations (F4 & F5), guar gum and xanthan gum were incorporated to induce flotation and swelling and retard the release of a drug. The precompression characteristics of tablets depict the suitability of all formulation powder for direct compression. The ATR-FTIR analyses have shown that the components of both effervescent and noneffervescent tablets are compatible with each other. The total weight of each tablet was 600 mg, with a weight variation of about ≤10 mg. Both the layers were smooth and flat with a thickness ranging from 3.16±0.04 to 3.54±0.01 mm. The diameters of prepared floating tablets were about 15 mm, optimum for oral administration. After adjusting the tablet’s hardness to 6-7 kg/cm2, its friability was found to be <0.35 percent. The mean drug content of the formulations was above 90%. The floating lag time of all formulations (F2-F5) was below 25 seconds, except F1 which took almost 50 seconds to start floating on the surface of gastric content due to its higher density. The total floating time of effervescent (F1-F3) and noneffervescent formulations was in the range of 15-25 hours, thereby providing sufficient time to complete drug release and absorption in the gastric area. The total floating time of noneffervescent formulations was higher (p≤0.05) than effervescent formulations due to efficient wettability and swelling characteristics. The release of drugs from both layers of noneffervescent tablets was significantly controlled when compared to the effervescent system, and an anomalous non-Fickian diffusion was found for the drug release. The stability study of the optimized formulation proved the integrity and stability of the developed formulation. Thus, developed formulations are deemed suitable for controlled codelivery of active pharmaceutical ingredients for the effective treatment of H. pylori.

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A Review on Stability Testing Guidelines of Pharmaceutical Products

Cited by 9 publications

References 15 publications

Characteristics and Physical Stability of Nanoemulsion as a Vehicle for Anti-Aging Cosmetics: A Systematic Review

Characteristics and Physical Stability of Nanoemulsion as a Vehicle for Anti-Aging Cosmetics: A Systematic Review

Eff ects of Non-standard Storage Conditions on the Stability, Safety and Suitability of Drug Consumption

Controlled Release Bilayer Floating Effervescent and Noneffervescent Tablets Containing Levofloxacin and Famotidine

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