Excipient Stability in Oral Solid Dosage Forms: A Review

Darji, Mittal; Lalge, Rahul; Marathe, Sushrut; Mulay, Tarul D; Fatima, Tasnim; Alshammari, Alia; Lee, Hyung Kyung; Repka, Michael A.; Murthy, S. N. B.

doi:10.1208/s12249-017-0864-4

Cited by 72 publications

(54 citation statements)

References 102 publications

(108 reference statements)

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“…The oral route is the most frequently used for drug administration, due to its simplicity and low cost (specialized staff is not required) [1,2]. In addition, oral solid pharmaceutical forms (tablets, capsules) generally have good physicochemical stability and easy dosing.…”

Section: Introductionmentioning

confidence: 99%

Microneedle-Based Delivery: An Overview of Current Applications and Trends

et al. 2020

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Microneedle arrays (MNA) are considered as one of the most promising resources to achieve systemic effects by transdermal delivery of drugs. They are designed as a minimally invasive, painless system which can bypass the stratum corneum, overcoming the potential drawbacks of subcutaneous injections and other transdermal delivery systems such as chemical enhancers, nano and microparticles, or physical treatments. As a trendy field in pharmaceutical and biomedical research, its applications are constantly evolving, even though they are based on very well-established techniques. The number of molecules administered by MNA are also increasing, with insulin and vaccines administration being the most investigated. Furthermore, MNA are being used to deliver cells and applied in other organs and tissues like the eyes and buccal mucosae. This review intends to offer a general overview of the current state of MNA research, focusing on the strategies, applications, and types of molecules delivered recently by these systems. In addition, some information about the materials and manufacturing processes is presented and safety data is discussed.

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Section: Introductionmentioning

confidence: 99%

Microneedle-Based Delivery: An Overview of Current Applications and Trends

et al. 2020

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“…Mannitol was chosen as diluent in a fixed weight to improve mouth feeling, taste, and for its solubility and wettability. [21] Aerosil as glidant to improve flowability, especially with direct compression processes [22] and sodium stearate as lubricant for its higher water solubility than magnesium stearate. [23] Sodium starch glycolate (SSG) was chosen as superdisintegrant, [24] Avicel, as a channeling agent to improve water absorption by tablets [25] and in low concentration to avoid tablet overweight.…”

Section: Formulation and Doementioning

confidence: 99%

“…Dissolution test (for the optimized formula) was performed later using USP Type II apparatus. Six tablets were put in the vessels each containing 900 of phosphate buffer pH 6.8 and temperature 37 ± 0.5 o C. Samples were taken in time schedule (5,10,20,30,40,50, and 60 min), filtered and concentration of both APIs was determined using a validated method above.…”

Section: Evaluation Of the Prepared Tabletsmentioning

confidence: 99%

“…It exhibits the highest stability among other dosage forms. [10] Orodispersible tablets (ODTs) have gained a good acceptability among people, especially those with swallowing difficulties and young patients. [11] ODTs are defined by the European Pharmacopeia (EP) as "uncoated tablet intended to be placed in mouth where they disperse rapidly before ORIGINAL ARTICLE being swallowed.…”

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Al-Ani¹

2019

AJP

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Introduction: Combination therapy is gaining high attention in pharmaceutical industry. It provides many advantages in accuracy of dose and patient compliance, especially in pediatrics. This work aims to formulate successful fixeddose combination pediatric oral dosage form as orodispersible tablets (ODTs) which contain a combination of amoxicillin 125 mg as an antibiotic and ibuprofen 100 mg per tablet for the treatment of several pediatric illnesses that need this combination. Materials and Methods: Design of experiment (DoE) was used to design the best formula for the proposed combination. The selection of non-active materials based on the improvement of tablet characteristics, taste, and safety. Then, DoE was used to predict the best combination of additives that give the best criteria of ODTs. The three responsive factors were wetting time and disintegration time and dissolution of both drugs taken as 70% of drug is dissolved at or in <30 min. Moreover, the three materials which were found to affect these responsive factors are sodium starch glycolate, Avicel, and sucrose. The optimized formula then was prepared and evaluated. Results and Discussion: Results were treated and the best combination of the affecting materials was confirmed by DoE that fitted the criteria of ODT. The optimized formula gave results which were very close to the predicted results by the DoE regarding the three response factors. Conclusion: Successful design was achieved using DoE, economic, and easy in production and achieved the goals of the design.

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“…Degradation of excipients in solid dosage forms may be a critical factor in its instability. This include degradation of antimicrobial preservatives, fading of dyes used to colour products or degradation of antioxidants (Darji et al, 2018). In the present study, the effects of moisture on the physical properties (such as dissolution profiles) of controlled release theophylline matrix tablets containing release enhancers will be investigated.…”

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confidence: 99%

Effects of Humidity on the Dissolution Profiles of Controlled Release Theophylline Matrix Tablets Containing Release Enhancers Prepared By Melt Granulation and Coacervation Techniques

Avbunudiogba¹

2020

jasem

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The quantity of moisture present in tablets plays a major role in influencing the physical/chemical properties of tablets especially dissolution profiles. The purpose of the present study is to investigate the effects of relative humidity on the dissolution profiles of controlled release theophylline matrix tablets containing release enhancer prepared by melt granulation and simple coacervation techniques. Sucrose and microcrystalline cellulose at concentration of 3% w/w, 5% w/w, 7.5% w/w, and 10% w/w were included in the blends as release enhancers before compression into nondisintegrating matrix tablets. Resulting tablets were exposed to 0% and 75% relative humidity. Sample were withdrawn at 0, 15 days, 1 month, 2 months and 3 months and evaluated for cumulative drug release. Interactions were investigated using modern technology: Differential scanning calorimetry (DSC). Initial and maximum release were increased after exposure to 75% relative humidity. There was no drug – excipients interaction. Thus moisture increased theophylline release from both sets of tablets prepared by melt granulation and simple coacervation techniques. Keywords: Theophylline, Matrix tablets, Dissolution profiles, Release enhancers, Relative humidity

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Excipient Stability in Oral Solid Dosage Forms: A Review

Cited by 72 publications

References 102 publications

Microneedle-Based Delivery: An Overview of Current Applications and Trends

Microneedle-Based Delivery: An Overview of Current Applications and Trends

Untitled

Effects of Humidity on the Dissolution Profiles of Controlled Release Theophylline Matrix Tablets Containing Release Enhancers Prepared By Melt Granulation and Coacervation Techniques

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