The preparation of orally disintegrating tablets using a hydrophilic waxy binder

Abdelbary, Ghada A.; Prinderre, P.; Eouani, C.; Joachim, J; Reynier, Jean-Pierre; Piccerelle, Philippe

doi:10.1016/j.ijpharm.2004.03.023

Cited by 83 publications

(66 citation statements)

References 14 publications

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“…4,5) To overcome this issue, a variety of pharmaceutical studies have been conducted to develop new dosage forms. Among the dosage forms developed to facilitate ease of medication, the orally disintegrating tablet (ODT) is one of the most widely employed in commercial products.…”

Section: )mentioning

confidence: 99%

Preparation and Evaluation of Orally Disintegrating Tablets Containing Vitamin E as a Model Fat-Soluble Drug

Ikematsu

Uchida

Namiki

2015

CHEMICAL & PHARMACEUTICAL BULLETIN

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The purpose of the present study was to develop orally disintegrating tablets (ODTs) containing fatsoluble drugs that disintegrate rapidly while having appropriate tablet strength. We chose vitamin E (VE) as a model drug; d-α-tocopheryl acetate, as the oily VE (VE-OI), and d-α-tocopheryl acid succinate, as the powder VE (VE-PO), were used. The oily VE was added directly to ODTs (VE-OI ODTs) and also used for the preparation of two types of VE granule, i.e., granules prepared using adsorption to calcium silicate (VE-FL granules) and granules prepared using spray-drying with gelatin (VE-SD granules); each type of granule was added to ODTs (VE-FL ODTs and VE-SD ODTs). Powder VE was added directly to ODTs (VE-PO ODTs). Various VE ODTs were prepared using these four additional methods with varying amounts of VE per tablet and were evaluated with respect to their manufacturability, physicochemical characteristics, and stability. It was demonstrated that a tablet porosity of 30% to 35% and tensile strength of 7 kg/cm 2 or greater are required to provide VE ODTs with rapid disintegration and appropriate tablet strength, and that VE-SD granules and powder VE are suitable forms of VE to be added. When stability tests of VE-SD ODTs and VE-PO ODTs were performed, VE-PO ODTs exhibited prolongation of disintegration time and increased tensile strength, whereas VE-SD ODTs showed none of these changes. These changes were thought to be attributable to a decrease in the pore size of VE-PO ODTs resulting from the softening and migration of powder VE under hot storage conditions. Key words orally disintegrating tablet; fat-soluble drug; vitamin E; disintegration; tensile strength; porosity Most pharmaceutical dosage forms for oral administration are developed for drug delivery after swallowing. In particular, tablets and capsules are the most common oral solid dosage forms, because they are convenient to carry, the duration of action of the contained drugs can be controlled, 1) and their taste or smell can be improved. 2)However, many geriatric and pediatric patients often have difficulties swallowing conventional tablets or capsules.3) It is estimated that 50% of the population experiences this problem, which results in a high prevalence of non-compliance and ineffective therapy. 4,5) To overcome this issue, a variety of pharmaceutical studies have been conducted to develop new dosage forms. Among the dosage forms developed to facilitate ease of medication, the orally disintegrating tablet (ODT) is one of the most widely employed in commercial products. 6)Numerous studies have therefore been performed on the various compositions of and manufacturing methods for ODTs. For example, ODTs can be prepared by several manufacturing methods, e.g., lyophilization, 7) granulation, 8) the cotton candy process, 9) and phase transition of sugar alcohols by direct compression. 10,11) The oily type of fat-soluble drugs have generally been produced and marketed commercially in soft capsule form, 12) though some prescription and over-the-counter d...

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Section: )mentioning

confidence: 99%

Preparation and Evaluation of Orally Disintegrating Tablets Containing Vitamin E as a Model Fat-Soluble Drug

Ikematsu

Uchida

Namiki

2015

CHEMICAL & PHARMACEUTICAL BULLETIN

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“…The FDT technology should be versatile enough to accommodate unique properties of each drug. [14] The drugs belonging to Biopharmaceutical Classification System Class II, i.e., the drugs with poor solubility and high permeability are best suitable moieties for FDTs in a dose of 125 and 250 mg.[1516] Tizanidine HCl,[1] Oxybutynin HCl,[2] Rofecoxib,[3] Ibuprofen,[4] Promethazine Theoclate,[17] prednisone,[18] Indomethacin,[19] Glyburide,[20] Fentanyl citrate,[21] Griseofulvin,[22] Hydrochlorothiazide,[23] Crystallized Paracetamol,[24] and Nimesulide[25] are few examples of drugs that has been formulated as fast-dissolving drug delivery system.…”

Section: Desired Characteristics and Development Challenges Of Fast Dmentioning

confidence: 99%

“…Crystallized paracetamol was used as model drug and in addition, the formulation included mannitol as a water-soluble excipient and croscarmellose sodium as disintegrating agent. [24]…”

Section: Formulation Processes For Making Fast-dissolving Tabletsmentioning

confidence: 99%

Fast disintegrating tablets: Opportunity in drug delivery system

Parkash¹,

Maan²,

Deepika³

et al. 2011

J Adv Pharm Technol Res

143

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Fast disintegrating tablets (FDTs) have received ever-increasing demand during the last decade, and the field has become a rapidly growing area in the pharmaceutical industry. Oral drug delivery remains the preferred route for administration of various drugs. Recent developments in the technology have prompted scientists to develop FDTs with improved patient compliance and convenience. Upon introduction into the mouth, these tablets dissolve or disintegrate in the mouth in the absence of additional water for easy administration of active pharmaceutical ingredients. The popularity and usefulness of the formulation resulted in development of several FDT technologies. FDTs are solid unit dosage forms, which disintegrate or dissolve rapidly in the mouth without chewing and water. FDTs or orally disintegrating tablets provide an advantage particularly for pediatric and geriatric populations who have difficulty in swallowing conventional tablets and capsules. This review describes various formulations and technologies developed to achieve fast dissolution/dispersion of tablets in the oral cavity. In particular, this review describes in detail FDT technologies based on lyophilization, molding, sublimation, and compaction, as well as approaches to enhancing the FDT properties, such as spray drying and use of disintegrants. In addition, taste-masking technologies, experimental measurements of disintegration times, and dissolution are also discussed.

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“…The time in seconds taken for complete disintegration of the tablet with no palatable mass remaining in the apparatus was measured in seconds. Disintegration test was carried out in distilled water as medium[7]. All evaluation parameters are given in Table 3.…”

mentioning

confidence: 99%

Formulation and evaluation of mouth dissolving tablets of cinnarizine

Patel¹,

Patel²,

Rajput³

et al. 2010

Indian J Pharm Sci

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The purpose of this research was to develop mouth dissolve tablets of cinnarizine by effervescent, superdisintegrant addition and sublimation methods. All the three formulations were evaluated for disintegration time, hardness and friability, among these superdisintegrant addition method showed lowest disintegration time; hence it was selected for further studies. Further nine batches (B1-B9) were prepared by using crospovidone, croscarmellose sodium and L-HPC in different concentrations such as 5, 7.5 and 10%. All the formulations were evaluated for weight variation, hardness, friability, drug content, in vitro disintegration time, wetting time, in vitro dissolution. Formulation with 10% L-HPC showed the less disintegration time (25.3 s) and less wetting time (29.1 s). In vitro dissolution studies showed total drug release at the end of 6 min.

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The preparation of orally disintegrating tablets using a hydrophilic waxy binder

Cited by 83 publications

References 14 publications

Preparation and Evaluation of Orally Disintegrating Tablets Containing Vitamin E as a Model Fat-Soluble Drug

Preparation and Evaluation of Orally Disintegrating Tablets Containing Vitamin E as a Model Fat-Soluble Drug

Fast disintegrating tablets: Opportunity in drug delivery system

Formulation and evaluation of mouth dissolving tablets of cinnarizine

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