Evaluation of hard gelatin capsules and hydroxypropyl methylcellulose containing ampicillin

Weigert, Graziella Gonçalves; Ineu, Aniéle Posser; Gomes, Patrícia

doi:10.1590/s0100-40422012000200010

Cited by 4 publications

(4 citation statements)

References 7 publications

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“…Drug Product Disintegration: The impact of capsule opening, , or tablet disintegration, on the dissolution profile has been widely presented in the literature. Since dissolution models assume that all the drug particles are available at time zero for dissolution, the disintegration time or capsule opening time should be removed from the observed dissolution data prior to fitting the dissolution rate.…”

Section: Discussionmentioning

confidence: 99%

“…103,104 The presence of cosolvents or polymers can also change the rate and extent of surface precipitation, 105 and, where relevant, such excipients should be considered critical to the product performance. 106 Drug Product Disintegration: The impact of capsule opening, 107,108 or tablet disintegration, 109 on the dissolution profile has been widely presented in the literature. Since dissolution models assume that all the drug particles are available at time zero for dissolution, the disintegration time or capsule opening time should be removed from the observed dissolution data prior to fitting the dissolution rate.…”

Section: Q4: Which Are the Factors To Be Considered When Modeling Dis...mentioning

confidence: 99%

See 1 more Smart Citation

Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report

Pepin,

Arora,

Borges

et al. 2024

Mol. Pharmaceutics

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This Article shares the proceedings from the August 29th, 2023 (day 1) workshop "Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives". The focus of the day was on model parametrization; regulatory authorities from Canada, the USA, Sweden, Belgium, and Norway presented their views on PBBM case studies submitted by industry members of the IQ consortium. The presentations shared key questions raised by regulators during the mock exercise, regarding the PBBM input parameters and their justification. These presentations also shed light on the regulatory assessment processes, content, and format requirements for future PBBM regulatory submissions. In addition, the day 1 breakout presentations and discussions gave the opportunity to share best practices around key questions faced by scientists when parametrizing PBBMs. Key questions included measurement and integration of drug substance solubility for crystalline vs amorphous drugs; impact of excipients on apparent drug solubility/supersaturation; modeling of acid−base reactions at the surface of the dissolving drug; choice of dissolution methods according to the formulation and drug properties with a view to predict the in vivo performance; mechanistic modeling of in vitro product dissolution data to predict in vivo dissolution for various patient populations/species; best practices for characterization of drug precipitation from simple or complex formulations and integration of the data in PBBM; incorporation of drug permeability into PBBM for various routes of uptake and prediction of permeability along the GI tract.

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Section: Discussionmentioning

confidence: 99%

Section: Q4: Which Are the Factors To Be Considered When Modeling Dis...mentioning

confidence: 99%

Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report

Pepin,

Arora,

Borges

et al. 2024

Mol. Pharmaceutics

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“…On the other hand, gelatine capsule is soluble in biological fluids at body temperature and can release its content quickly. 27 This explains why freeze-dried propolis powder in hard gelatine capsules disintegrated faster than in hard HPMC capsules.…”

Section: In Vitro Disintegration Testmentioning

confidence: 99%

Encapsulation of Freeze-dried Propolis Powder: Study of in vitro Disintegration and Dissolution

Zainal¹,

Enidran²,

Ganesan³

2021

IJPER

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Propolis is a resinous material collected by bees from various plant sources. Propolis has been used since ancient times for medicinal purposes. In this study, the propolis extracts were dried using a freeze-drying technique to preserve its medicinal properties. The effect of different freezing temperatures on the yield and propolis powder flow ability characteristics was evaluated. The potential of propolis powder to be encapsulated in hard gelatin capsules and hard hydroxypropyl methylcellulose (HPMC) capsules were investigated. The mass uniformity, in vitro disintegration and dissolution performance of the propolis powder in hard gelatine capsules and hard HPMC capsules were determined after encapsulation. The amount of propolis powder produced after freeze-drying decreased with decreasing of freezing temperature from -50°C to -80°C. Propolis powder obtained at -80°C of freezing temperature showed excellent flow ability characteristics. The average mass of propolis powder in hard gelatine capsules and the propolis powder in hard HPMC capsules was 0.5578 ± 0.019g and 0.5559 ± 0.020 g, respectively. In vitro disintegration test showed that the propolis powder that was loaded into the hard gelatine capsules disintegrated faster than the propolis powder loaded into the hard HPMC capsules, which were 1.7 to 7.8 min and 3.7 to 8.4 min in all four media solutions. Among the dissolution media tested, 1 % SLS in water showed the highest release of flavonoid. The studies of an encapsulated form of propolis powder are recommended prior to the release of a dietary supplement or clinical trial investigational product to ensure its efficacy.

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“…Graziella Gonçalves Weigert, yapmış olduğu çalışmada ampisilin içeren sert jelatin kapsüller ve HPMC kapsüllerinde dezentegrasyon testi yapıldığında sert jelatin kapsüllerin beş dakikada içinde dağıldığı, ampisilin içeren HPMC kapsüllerin ise yedi dakikada dağıldığı belirtilmiştir. Bunun sebebi ise HPMC'nin selülozdan üretilmesi ve kolayca nemlenmesi ancak şişmesi ve dağılmasının vücut ısısında daha uzun zaman almasıdır7 . Bu çalışmada sert jelatin kapsüller HPMC kapsüllere göre dağılmada ve sıkıştırılmada üstünlük göstermiştir.…”

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Quality Control of Hard Gelatin Capsules Containing Rheum Ribes L. Extract and Investigation of Its Effects on Oxidative Stress

Yıldırım

Eker

Çobanoglu

et al. 2020

Mersin Üniversitesi Tıp Fakültesi Lokman Hekim Tıp Tarihi Ve Folklorik Tıp Dergisi

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Rheum türleri tıbbi öneme sahiptir. Rheum ribes L. yerel olarak Işkın, Uçkun veya Uşgun olarak bilinmektedir. Genellikle Lübnan'da, İran'da ve Türkiye'nin doğusunda yetişmektedir. Rheum ribes L. bitkisinin çeşitli bölümlerinden elde edilmiş ekstraktlar birçok hastalığın tedavisinde kullanılmaktadır.Bu çalışmada, Anadolu folklorik tıbbında diyabet, hemoroid, ülser ve diyare tedavisinde kullanılan Rheum ribes L. bitkisinin ekstraktının hazırlanması, elde edilen toz ekstraktlarının Avrupa Farmakopesine uygun olarak toz kontrollerinin yapılması, hazırlanan ekstraktın sert jelatin kapsül formülasyonunun elde edilmesi ve Rheum ribes L. ektstraktını içeren sert jelatin kapsüllerin kapsül kalite kontrol çalışmalarının yapılması ile birlikte bitkisel ekstraktın in vitro olarak antioksidan özellik gösterip göstermediği incelenmiştir. Yöntem: Rheum ribes L. bitkisi 2016 yılında Metin Yıldırım tarafından Nisan-Mayıs aylarında toplanmıştır. Sert jelatin kapsüllere dolumu gerçekleştirilen Rheum ribes L. ekstraktlarında yığın dansitesi, sıkıştırılmış dansite, sıkıştırılabilirlik indeksi, Hausner oranı, akış süresi, yığın açısı tayini, elek analizi, dolumu yapılan sert jelatin kapsüllere ise dağılma testi, ağırlık sapması testi yapılmıştır. Bitki ekstraktının antioksidan aktivitesi 1,1-Difenil 2-Pikril Hidrazil (DPPH) metodu ile ölçülmüştür. Bulgular: Elde edilen sonuçlara göre yığın açısı 26.66±0.3o, yığın dansitesi 0.37±0.06 g/ml, sıkıştırılmış dansite 0.46±0.09 g/ml, elek analizinin sonucuna göre d50: 214.734±12.36 µm, d90: 43.99±2.92 µm bulunmuş olup, yapılan dağılma testinde ise suni mide vasatında 1 dakika 12 saniyede, suni barsak vasatında 2 dakika 10 saniyede kapsüller dağılma göstermiştir. Dolumları yapılan kapsüllerde ağırlık sapması 250.16±1.85 mg'dır. Rheum ribes L. ekstraktının IC50'si 74.1±4.8 µg /ml olarak bulunmuştur. Sonuç: Elde edilen verilere göre, Avrupa Farmakopesi baz alındığında kapsüllere dolum yapılan tozun akışkanlığı mükemmel, elek analizi sonucuna göre tozun inceliği çok kaba olarak bulunmuştur. Bu sonuçlara göre; Rheum ribes L. ekstraktı içeren sert jelatin kapsüllerin formülasyon açısından bir sorun teşkil etmediği ve piyasada gıda takviyesi olarak kullanılabileceği düşünülmektedir.

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Evaluation of hard gelatin capsules and hydroxypropyl methylcellulose containing ampicillin

Cited by 4 publications

References 7 publications

Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report

Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report

Encapsulation of Freeze-dried Propolis Powder: Study of in vitro Disintegration and Dissolution

Quality Control of Hard Gelatin Capsules Containing Rheum Ribes L. Extract and Investigation of Its Effects on Oxidative Stress

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