Influence of Non-Water-Soluble Placebo Pellets of Different Sizes on the Characteristics of Orally Disintegrating Tablets Manufactured by Freeze-Drying

Stange, Ulrike; Führling, Christian; Gieseler, Henning

doi:10.1002/jps.23517

Cited by 8 publications

(12 citation statements)

References 37 publications

(76 reference statements)

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“…The results of the present study are confirmed by a previous study of Stange et al in which placebo pellets with a narrow particle size distribution were incorporated into freeze‐dried tablet matrices. Here, an increase in ODT hardness was found for addition of non‐water‐soluble placebo pellets.…”

Section: Resultssupporting

confidence: 89%

“…SEM pictures of the previous study revealed that the surface of the NaS granules was fully coated with amorphous Eudragit® E. Hence, coated granules and solutes are present in the same physical (amorphous) state that is considered a fundamental prerequisite for effective interactions between both. A lack of interaction was reported previously for amorphous placebo pellets and crystalline mannitol applied in ODTs . In this case, the TH was found inadequate.…”

Section: Resultssupporting

confidence: 50%

“…Here, an increase in ODT hardness was found for addition of non‐water‐soluble placebo pellets. However, the location of the particles in the tablets was controlled by a two‐step freezing process, leading to a central particle layer that may impact the hardness . Note that in the present study, neither the freezing process nor the location of the coated granules was controlled throughout the manufacturing process.…”

Section: Resultsmentioning

confidence: 80%

“…The target mass of taste‐masked NaS granules was then accurately weighed (±2 mg) into each blister mold. The first experiments were performed according to the previously conducted study with placebo pellets . Therefore, 2 mL of the respective solutions (A–D) were added (cf.…”

Section: Methodsmentioning

confidence: 99%

See 3 more Smart Citations

Formulation, Preparation, and Evaluation of Novel Orally Disintegrating Tablets Containing Taste-Masked Naproxen Sodium Granules and Naratriptan Hydrochloride

Stange

Führling²,

Gieseler

2014

Journal of Pharmaceutical Sciences

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Section: Resultssupporting

confidence: 89%

Section: Resultssupporting

confidence: 50%

Section: Resultsmentioning

confidence: 80%

Section: Methodsmentioning

confidence: 99%

See 2 more Smart Citations

Formulation, Preparation, and Evaluation of Novel Orally Disintegrating Tablets Containing Taste-Masked Naproxen Sodium Granules and Naratriptan Hydrochloride

Stange

Führling²,

Gieseler

2014

Journal of Pharmaceutical Sciences

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“…Liyofilizasyon tekniği ile etken madde içeren çözelti, süspansiyon veya emülsiyonların kullanılması mümkündür. 34 Üstünlüklerinin yanında dondurarak kurutma yön-temi pahalı ve zaman alıcı bir yöntem olmakla birlikte, elde edilen tabletler çok kırılgan yapıya sahiptir ve bu tabletlerin çevresel koşullara karşı stabiliteleri çok düşüktür. 35 …”

Section: Deformasyon Mekanizmasıunclassified

Orally Disintegrating Tablets: General Overview and Quality by Design Approach: Review

Tashan¹,

Karakucuk²,

Çelebi³

2017

Turkiye Klinikleri J Pharm Sci

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Ö ÖZ ZE ET T Bütün farmasötik dozaj formları arasında tabletler, en çok tercih edilen ve uygulanan katı dozaj formlarıdır. Ağızda dağılan tabletler (ADT) ise son zamanlarda birçok hastalığın tedavisinde önem kazanan katı dozaj formları olmuştur. Tabletlerin dil üzerine yerleştirildikten sonra ağızda hoş bir his bırakarak çok kısa sürede dağılması ya da çözünmesi ve kullanım sırasında suya ihtiyaç duyulmaması özellikle yaşlı ve çocuk hastalar ile yutma problemi (disfaji) olanların tedaviye daha kolay uyum sağlaması ağızda dağılan tablet teknolojilerinin geliştirilmesinde çok önemli etkenler olmuştur. Tedavide hızlı etki göstermesi beklenen antiemetik, antipsikotik, analjezik, antiepileptik gibi farmakolojik gruplardaki etken maddeler ADT olarak formüle edilebilir. ADT'lerin üretiminde çeşitli konvansiyonel ve patentli teknolojiler söz konusu olmakla birlikte, tabletlerin geliştirilme-sinde ve üretim işleminde tasarımla kalite yaklaşımının uygulandığı birçok çalışma mevcuttur. Tasarımla kalite yaklaşımı ile kritik kalite özellikleri ve kaliteli hedef ürün profili belirlenerek tüm proçesin önceden tasarlanması ile risk yönetiminin yapılmasını, proçesin daha iyi anlaşılmasını, olası risklerin azaltılmasını ve istenilen kalite profilinde tasarım alanının oluşturulmasını sağlar. Tasarım alanı içerisinde çalışma olanağı, hasta ve üretici yararına daha esnek ruhsatlandırma yaklaşımları sunarak, daha düşük maliyette daha kaliteli ürün üretilmesine olanak tanır. Bu çalışma kapsamında, ADT'lerin mevcut üretim yöntemleri, patentli üretim teknolojileri ve ADT formülas-yonlarında kullanılan süper dağıtıcıların özelliklerinin yanı sıra, istenen kalitede ADT'lerin geliş-tirilmesinde tasarımla kalite yaklaşımı ile ilgili bilgiler ve araştırmalar değerlendirilmiştir.A An na ah ht ta ar r K Ke el li im me el le er r: : Tabletler; uygulama, ağızdan; teknoloji, farmasötik; dozaj formları A AB BS ST TR RA AC CT T Among all solid pharmaceutical dosage forms tablets are the most preferred and used dosage forms. Recently, orally disintegrating tablets (ODTs) had become favorite as solid dosage forms for treatment of many diseases. Disintegration or dissolution of tablets in a very short time with nice taste after placing on tongue, no need to drink water during use and well compliance in treatment specially for pediatric and geriatric patients and patients with difficulties in swallowing (dysphagia) are very important considerations for development of ODT technologies. Active ingredients belong to many pharmacological groups like antiemetic, antipsychotic, analgesic, antiepileptic which are expected to show immediate effect in treatment can be formulated as ODTs. There are various conventional methods and patented technologies to produce ODTs as well as there are a lot of studies which apply quality by design (QbD) approach through development and production process of tablets. Quality by design approach determined by critical quality attributes and quality target product profile provides performing risk management with pre-designing of...

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Modified‐release oral pellets for duodenum delivery of doxycycline hyclate

Huang

et al. 2019

Drug Development Research

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To minimize the gastric and esophageal injury effect, a system to deliver doxycycline hyclate (DOXY) to the duodenum area is needed. DOXY‐containing modified‐release oral pellets (DMOP) coated with hydroxypropyl methylcellulose phthalate HP‐55 (HPMCP HP‐55) and hydroxypropyl methylcellulose E15 (HPMC E15) appear to be a reasonable choice. This coating layer dissolves at pH 5.5, which is the pH of the duodenum, but not at a gastric pH (1.2). The formulation and preparation of DMOP were optimized, and a scale‐up test was performed. The results showed that the production reproducibility was acceptable, and the quality of DMOP well met the standards of Chinese Pharmacopeia (Ch.P, 2015 edition). Notably, the accumulated DOXY release was lower than 50% at pH 1.2 (20 min) and higher than 85% at pH 5.5, which met the USP40‐NF35 standard for DOXY modified‐release formulations. Moreover, the storage stability of DMOP with different packages was investigated by stress testing, accelerated and long‐term testings. The stability of DMOP was maintained up to 12 months, in terms of DOXY content and in vitro release behavior. The results seem to suggest that DMOP could be a promising duodenum delivery system.

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Influence of Non-Water-Soluble Placebo Pellets of Different Sizes on the Characteristics of Orally Disintegrating Tablets Manufactured by Freeze-Drying

Cited by 8 publications

References 37 publications

Formulation, Preparation, and Evaluation of Novel Orally Disintegrating Tablets Containing Taste-Masked Naproxen Sodium Granules and Naratriptan Hydrochloride

Formulation, Preparation, and Evaluation of Novel Orally Disintegrating Tablets Containing Taste-Masked Naproxen Sodium Granules and Naratriptan Hydrochloride

Orally Disintegrating Tablets: General Overview and Quality by Design Approach: Review

Modified‐release oral pellets for duodenum delivery of doxycycline hyclate

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