ABSTRACT
Among the various routes of administration, the oral route remains the most convenient and commonly employed route for drug delivery. The oral conventional drug delivery systems have some drawbacks, such as possibility of gastrointestinal destruction of labile molecules, low absorption of macromolecules, slow onset of action, and unavoidable fluctuation in the concentration of drugs which can either lead to under- or over medication with concomitant adverse effects, especially for drugs with small therapeutic index. Therefore, it became essential to design novel oral drug delivery systems to achieve quick dissolution, absorption, rapid onset of action and reduction of drug dose. Among those novel drug delivery systems are oral disintegrating tablets (ODTs). The purpose of this review article is to report the recent advances in ODT systems with emphasis on their preparations, characterizations and applications.
ABSTRACT
Objective:To prepare aripiprazole oral disintegrating tablets , investigate the formula and evaluate the quality .Meth-ods:The formula of aripiprazole oral disintegrating tablets was investigated by a factorial experiment design .The aripiprazole particle size distribution ( X1 , D90/μm) , the ratio of mannitol to microcrystalline cellulose ( X2 ,％) and the amount of disintegration ( X3 ,％) were selected as the independent variables , and the tablet hardness ( Y1 , N) , the disintegration time ( Y2 , s) and the dissolution in 30 min ( Y3 ,％) were used as the dependent variables to ultimately determine the optimal formula .The dissolution profile of aripiprazole oral disintegrating tablets and the reference preparation in four dissolution media were compared by f2 similarity factor, and the stability of aripiprazole oral disintegrating tablets was investigated by accelerated stability testing .Results: The results of factorial experiment design of variance analysis showed that the filler ratio had significant effect on the tablet hardness (P<0.05), the amount of disinte-grant and the filler ratio had significant effect on the disintegration time (P<0.05), and the aripiprazole particle size had significant effect on the drug dissolution ( P<0.05 ) .The optimal formula of aripiprazole oral disintegrating tablets was as follows: the particle size D90 of aripiprazole was 20-40μm, the amount ratio of mannitol to microcrystalline cellulose was 2.5:1, and the amount of disinte-gration was 5.0％.Aripiprazole oral disintegrating tablets prepared with the optimal formula had higher hardness , shorter disintegration time and faster drug dissolution , and the dissolution profiles were similar with those of the reference preparation .The relevant sub-stances showed no significant increase during the accelerated stability testing , and the quality was satisfactory .Conclusion:The formu-la of aripiprazole oral disintegrating tablets is reasonable , the preparation process is feasible and the quality is controllable .
ABSTRACT
Desloratadine (DS) is a tricyclic antihistaminic, characterized by bitter taste and slight water solubility. The aim of this study is to prepare DS as orally disintegrating tablets (ODT) to mask the bitter taste and improve compliance. Twelve different placebo ODT (F1-F12) were prepared using mannitol as diluent, in addition to functional excipients. The formulations were evaluated for relevant in vitro characteristics. DS powder was treated by different techniques and polymers (hydroxypropyl methyl cellulose (HPMC), Eudragit RL 30, and Eudragit EPO) for taste masking of DS. The placebo and DS- ODT tablets were assessed for taste masking efficiency by a panel of 10 volunteers. All placebo formulations were non sticky except four formulations (F8- F11), and compressible with the exception of F2. F12 showed the least disintegration time (20 sec) without sticking tendency.The compressible non sticky formulations were used for preparation of DS tablets and subjected to further in vitro evaluation. Fairly good weight uniformity values were observed in all the tested ODT formulations. F12 exhibiting the shortest wetting time (14.7 seconds) and the least disintegration time (20 seconds). 100% DS release was attained after 2.5 minDS-ODT, compared to 82% from conventional marketed tablets (Aerius®) at same time interval.
ABSTRACT
Over the recent past, many of the research groups are focusing their research on this technology. Amongst Oral drug delivery system Oral Strip Technology (OST) is gaining much attention. The advantages of OST are the administration to pediatric and geriatric patient population where the difficulty of swallowing larger oral dosage forms is eliminated. This technology has been used for local action, rapid release products and for buccoadhesive systems that are retained in the oral cavity to release drug in controlled fashion. OST offers an alternate platform for molecules that undergo first pass metabolism and for delivery of peptides. An ideal OST should have the following properties: high stability, transportability, ease of handling and administration, no special packaging material and/or processing requirements, no water necessary for application, and a pleasant taste. All these requirement are fulfilled by the oral films. The OST is a good tool for product life cycle management for increasing the patent life of existing molecules or products. Compared to some of the complicated and expensive process (like lyophilization) used to manufacture ODTs(Orally Disintegrating Tablets), the OST is relatively easy to fabricate,thus reducing the overall cost of the therapy. One of the reasons is that the buccal mucosa is less permeable and is thus not able to elicit a rapid onset of absorption and hence better suited for formulations that are intended for sustained release action. Further, the buccal mucosa being relatively immobile mucosa and readily accessible, it makes it more advantageous for retentive systems used for oral trans mucosal drug delivery. The primary disadvantage associated with buccal delivery route is the low flux that in turn results in low drug bioavailability. To overcome this hurdle, various buccal penetration enhancers have been studied which improve the absorption pattern of the molecules. The article shows OST encompassing materials used in OST, method of preparation, evaluation, applications, commercial technologies and future Business prospects of this technology.
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AIM:To optimize the formulation of breviscapine oral disintegrating tablets and preparation process. METHODS: To adopt the multifactor and multilevel uniform design to optimize the preparation prescription,disintegrating time as the assessment index. RESULTS: The tablets prepared were finer in appearance,disintegrated within 35 s,with desirable taste.The dissolution rate was faster than breviscapine ordinary tablets. CONCLUSION: Breviscapine oral disintegrating tablets achieve the goal of design and it is easy to operate.