Obtaining fast dissolving disintegrating tablets with different doses of melatonin

Muñoz, H.; Castán, Herminia; Clares, Beatriz; Ruíz, M. A.

doi:10.1016/j.ijpharm.2014.03.054

Cited by 17 publications

(16 citation statements)

References 12 publications

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“…ODTs must have ideal organoleptic characteristics. 3 Orodispersible tablets are applicable for people who have difficulties in swallowing and for active people when water is not available, in the case of motion sickness, sudden episodes of coughing during the common cold, allergic conditions, and bronchitis. Due to this, these dose forms are increasingly being recognized in both industry and among academics.…”

Section: Introductionmentioning

confidence: 99%

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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: Introductionmentioning

confidence: 99%

“…Due to the pleasant taste and ability to mask other flavors, sugars are most commonly used, which dissolve quickly in saliva because they are very soluble in water. 3 Ambroxol (AMB) is a metabolite of bromhexine with similar actions and uses. It is chemically described as trans-4-[(2-amino-3,5-dibromobenzyl)amino]-cyclohexanol.…”

Section: Introductionmentioning

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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“…are usually administered to patients prior to sleep time in order to facilitate sleep onset. A research group has manufactured fast dissolving disintegrating tablets containing different dosages of melatonin for administration to pediatric patients that may have potential difficulties taking other oral dosage forms [3]. Dosages of 3 and 5 mg were intended for epileptic children, migraine prevention, neurodevelopmental disability, sleep disorders, and blindness, whereas dosages of 10 and 60 mg were used for Duchenne muscular dystrophy.…”

Section: Melatonin Per Os Immediate Release Formulationsmentioning

confidence: 99%

Melatonin Modified Release Formulations Designed for Sleep Disorders

Vlachou¹,

Siamidi²

2018

Melatonin - Molecular Biology, Clinical and Pharmaceutical Approaches

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Melatonin (N-acetyl-5-methoxytryptamine, MLT), a hormone synthesized by the pineal gland and released at night, has a regulatory role on sleep in vertebrates, including humans. It has been shown to have a hypnotic action in animals and humans and it has been used as an agent for restoring circadian rhythms, disturbed by jet-lag, shift-work or aging. The physiological actions of melatonin in regulating seasonal and circadian rhythms are mediated through a family of specific, high affinity G protein-coupled membrane receptors. The beneficial effect of fast-release formulations on sleep initiation may come from the high amount of melatonin released immediately after administration, while the benefit of the sustained release systems comes from the release of melatonin in small dosages during the entire night period. This chapter covers the recent scientific work on melatonin modified release formulations.

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“…This technic is based on the direct compression of the formulation or on the compression of wet or dry granules (32). These orodispersibles disintegrate due to the presence of superdisintegrator, such as croscarmellose, crospovidone, sodium starch glycolate and calcium silicate (33), or due to the effect of effervescent components (34), added to the preparation in high concentration. Moreover, there is an addition of sugars of high aqueous solubility, such as mannitol, dextrose, fructose and lactyl that promote disintegration as well.…”

Section: Conventional Compressionmentioning

confidence: 99%

The Popularization of Orodispersible Tablets in the Pharmaceutical Market

Pinho

Temer

Ribeiro

et al. 2018

Infarma

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Orodispersible tablets are getting popular due to its easy administration which leads to a higher therapeutic adherence. This study aimed to evaluate the state of the art of these drug products based on the scientific literature. Also, orodispersible tablets available in the US, Europe and Brazil markets based on information extracted from the health agencies were analyzed. Those tablets are designed to be placed on the tongue and instantly disintegrated by the fast capitation of the saliva without the additional intake of water. The orodispersible technology enables oral administration of tablets to patients with dysphagia, especially children, and elderlies. Moreover, orodispersible make possible rapid drug intervention and mouth absorption. The drug is partially absorbed in the oral cavity, pharynx, and esophagus without first pass effect, increasing drug bioavailability and reaching faster therapeutic effect. This is a low-cost technology that fits in a conventional solid production area and adds value to the product without requiring high investment. A market analysis showed there is a predominance of antihistamine drugs or medicines for mental disorders using orodispersible matrices. However, the orodispersible technology shows great versatility and potential application to other pharmacological groups. It is expected that in coming years a massive commercial insertion of this tablet technology occurs. In this scenery, it is indispensable that health professionals are prepared with updated technical information for the use of this therapeutic resource safely and efficiently. RESUMOOs comprimidos orodispersíveis têm ganhado popularidade por serem de fácil administração e levarem a uma maior adesão terapêutica. Esse estudo teve como objetivo avaliar o estado da arte desses medicamentos com base na literatura científica. Adicionalmente, foram levantados os comprimidos orodispersíveis disponíveis nos mercados dos EUA, Europa e Brasil com base em informações extraídas das agências sanitárias dessas regiões. Esses comprimidos são concebidos para serem colocados na boca e instantaneamente desintegrados pela captação da saliva, sem a necessidade de água. A tecnologia orodispersível viabiliza a administração oral de comprimidos em usuários com disfagia. Adicionalmente, esses medicamentos possibilitam uma rápida intervenção medicamentosa e absorção bucal, fazendo com que uma fração do fármaco seja absorvido na cavidade oral, faringe e esôfago sem sofrer efeito de primeira passagem, incrementando sua biodispobibilidade e permitindo alcançar um efeito terapêutico mais rápido. O barateamento dessa tecnologia, que se adapta a áreas de produção de sólidos convencionais, agrega valor ao medicamento sem demandar alto investimento.

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Obtaining fast dissolving disintegrating tablets with different doses of melatonin

Cited by 17 publications

References 12 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

Melatonin Modified Release Formulations Designed for Sleep Disorders

The Popularization of Orodispersible Tablets in the Pharmaceutical Market

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