Compressed orally disintegrating tablets: excipients evolution and formulation strategies

Al-Khattawi, Ali; Mohammed, Afzal-Ur-Rahman

doi:10.1517/17425247.2013.769955

Cited by 64 publications

(34 citation statements)

References 54 publications

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“…The strong binding property of MCC is a result of its plastic deformation under pressure. Generally, plastic deformation occurs if the crystal structure or shape is changed under compression against 21 On the other hand, water-soluble materials such as PVP K-30 dissolve faster rather disintegrate. Therefore, as the optimum binder concentration, 1% MCC was selected for the final formulation of the AMB hydrochloride and salbutamol sulphate ODT.…”

Section: Optimization Of Pvp K-30 or MCC (Avicel Ph-102) Along With Tmentioning

confidence: 99%

Orally Disintegrating Tablets in Fixed Dose Combination containing Ambroxol Hydrochloride and Salbutamol Sulphate prepared by Direct Compression Technique: Formulation Design, Development and In-Vitro Evaluation

Sharma

Singh

2018

tjps

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ÖZAmaç: Solunum bozukluklarının tedavisi için oral-dağılan AMB hidroklorür ve salbutamol sülfat kombinasyon tabletlerinin (ODT) geliştirilmesi ve kombine süper dağıtıcıların uygun bağlayıcı ve eksipiyanlar ile kombine kullanımı ile in vitro değerlendirmenin yapılmasıdır. Tabletleri hazırlamak için doğrudan basım kullanıldı. Gereç ve Yöntemler: Bu araştırmada, oral dağılan tabletlerin formülasyonunda SNG konsantrasyonunu optimize etmek için farklı SNG konsantrasyonları süper dağıtıcı olarak kullanıldı. Farklı konsantrasyonlarda MCC ve PVP K-30 da optimize SNG konsantrasyonu ile birlikte çalışıldı. Tabletler, sertlik, Objectives: To design a formulation and develop ODTs of AMB hydrochloride and salbutamol sulphate in combination for the treatment of respiratory disorders and perform an in vitro evaluation using superdisintegrants in combination with a suitable binder and excipients. Direct compression was used to prepare the tablets. Materials and Methods: In the present research work, different concentrations of SSG as a superdisintegrant were used to optimize the concentration of SSG in the formulation of ODTs. Different concentrations of MCC and PVP K-30 were also studied along with the optimized SSG concentration. The tablets were evaluated for hardness, friability, weight variation, wetting time, in vitro DT, and percentage drug content uniformity. The optimized formulation was further evaluated in an in vitro release study, and drug-excipient compatibility and accelerated stability study. Results: The optimized concentration of SSG was found as 4% on the basis of the lowest DT. The 1% concentration of MCC was selected as the optimum binder concentration on the basis of the lowest DT. ODTs passed all the quality control tests viz., weight variation, hardness, friability, in vitro DT, drug content (%) and wetting time. The formulation satisfied the requirements of the FDA for rapid-dissolving tablets and allowed more than 85% drug to be released within 30 min. The fourier transform infrared spectroscopy study revealed that there was no interaction between the drug and excipients. The accelerated stability study shows that formulation is quite stable at normal temperature and humidity conditions as well as at extreme temperature conditions. Conclusion: By adopting a systematic formulation approach, ODTs of AMB hydrochloride and salbutamol sulphate in fixed-dose combination can be formulated using superdisintegrants in combination with appropriate binder and excipients; this was found to be economical and industrially feasible.

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Section: Optimization Of Pvp K-30 or MCC (Avicel Ph-102) Along With Tmentioning

confidence: 99%

Orally Disintegrating Tablets in Fixed Dose Combination containing Ambroxol Hydrochloride and Salbutamol Sulphate prepared by Direct Compression Technique: Formulation Design, Development and In-Vitro Evaluation

Sharma

Singh

2018

tjps

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“…For tablets, the understanding of major powder densification mechanisms under pressure and its effect on tablet properties is considered vital [3]. In general, tableting excipients deform elastically, plastically or by brittle fracture under pressure resulting in either strong and durable tablets or friable and fragile ones depending on the type of excipient/s employed [4].…”

Section: Introductionmentioning

confidence: 99%

Evidence-Based Nanoscopic and Molecular Framework for Excipient Functionality in Compressed Orally Disintegrating Tablets

et al. 2014

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The work investigates the adhesive/cohesive molecular and physical interactions together with nanoscopic features of commonly used orally disintegrating tablet (ODT) excipients microcrystalline cellulose (MCC) and D-mannitol. This helps to elucidate the underlying physico-chemical and mechanical mechanisms responsible for powder densification and optimum product functionality. Atomic force microscopy (AFM) contact mode analysis was performed to measure nano-adhesion forces and surface energies between excipient-drug particles (6-10 different particles per each pair). Moreover, surface topography images (100 nm2–10 µm2) and roughness data were acquired from AFM tapping mode. AFM data were related to ODT macro/microscopic properties obtained from SEM, FTIR, XRD, thermal analysis using DSC and TGA, disintegration testing, Heckel and tabletability profiles. The study results showed a good association between the adhesive molecular and physical forces of paired particles and the resultant densification mechanisms responsible for mechanical strength of tablets. MCC micro roughness was 3 times that of D-mannitol which explains the high hardness of MCC ODTs due to mechanical interlocking. Hydrogen bonding between MCC particles could not be established from both AFM and FTIR solid state investigation. On the contrary, D-mannitol produced fragile ODTs due to fragmentation of surface crystallites during compression attained from its weak crystal structure. Furthermore, AFM analysis has shown the presence of extensive micro fibril structures inhabiting nano pores which further supports the use of MCC as a disintegrant. Overall, excipients (and model drugs) showed mechanistic behaviour on the nano/micro scale that could be related to the functionality of materials on the macro scale.

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“…heat or humidity) were also proposed to produce hard tablets without 119 compromising disintegration time [13,14]. However, possible variations on the drug solid state limit the 120 application of these approach [12].…”

mentioning

confidence: 99%

“…And again, when freeze-dried 126 amorphous sucrose mixed with mannitol was compressed at low compression strength, crystallization of 127 the amorphous sucrose in the tablet occurred, increasing the tablet tensile strength without altering the 128 original tablet porosity [13]. Moreover, spray-drying is considered a valuable tool for the development of 129 tableting multifunctional excipients with improved flowability and porosity [12]. Similarly, freeze-drying 130 produces hybrid excipient with high porosity and specific surface area [7].…”

mentioning

confidence: 99%

Orodispersible dosage forms: biopharmaceutical improvements and regulatory requirements

Cilurzo

Franzè

Selmin

et al. 2018

Drug Discovery Today

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Compressed orally disintegrating tablets: excipients evolution and formulation strategies

Cited by 64 publications

References 54 publications

Orally Disintegrating Tablets in Fixed Dose Combination containing Ambroxol Hydrochloride and Salbutamol Sulphate prepared by Direct Compression Technique: Formulation Design, Development and In-Vitro Evaluation

Orally Disintegrating Tablets in Fixed Dose Combination containing Ambroxol Hydrochloride and Salbutamol Sulphate prepared by Direct Compression Technique: Formulation Design, Development and In-Vitro Evaluation

Evidence-Based Nanoscopic and Molecular Framework for Excipient Functionality in Compressed Orally Disintegrating Tablets

Orodispersible dosage forms: biopharmaceutical improvements and regulatory requirements

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