Abstract

Design, and in vitro evaluation of orodispersible tablets (ODTs) of rizatriptan

Drug delivery systems are becoming increasingly popular as medical scientists gain a better understanding of the physicochemical and biochemical parameters associated with their performance. Thirty years ago, oral contraceptive pills (ODTs) received a lot of attention as an alternative

Access to standard tablets and tablets thanks to better patient compliance ODTs are dosage forms containing therapeutic substances that disperse rapidly, usually in seconds, when placed on the tongue. ODT technology products entered the market in the 1980s, grew in demand, and the pipeline for their production increased rapidly. The new ODT technology addresses a wide range of medical and patient needs, ranging from improved health cycle management to easier withdrawal of pediatric, obstetrics and psychiatric disorders with dementia. This has encouraged academics and industry to discover new ways of dispersing the word and techniques in the field. The purpose of this article is to review ODTs development, construction challenges, new ODT technologies and testing methods,

The suitability of drug representatives, and the prospects for the future.

Drug delivery programs (DDS) are a strategic tool to increase markets / indicators, increase product life cycles and productive opportunities. DDS has made a significant contribution to global drug marketing by market segregation, and it is moving very fast. Breakfast tablets (ODT) are oral solid dosage forms that disintegrate in the oral cavity in easy swallow residue. Orally disintegrating tablets are also known as “Mouth dissolving tablets”, “Orodispersible  tablets”, “Melt- in-mouth Oral disintegratingdrug delivery, Rapimelts tablets, Porous tablets, Quick dissolving tablets” 2 etc.

Recently ODT terminology has been approved by United States Pharmacopoeia,  British  Pharmacopoeia,  and  Centre  for  Drug  Evaluation  and Research (CDER). US FDA defined ODT tablets as “A solid dosage form containing medicinal substances which disintegrates rapidly usually within a matter  of  seconds,  when  placed  upon  the  tongue”.  European  pharmacopoeia also adopted the term Orally disintegrating tablet as a tablet that is to be placed in  the  mouth  where  it  disperses,  rapidly  before  swallowing  despite  various terminologies   used.   Recently,   ODT   have   started   gaining   popularity   and acceptance as new drug delivery systems, because they are easy to administer and lead to better patient compliance especially in elderly and children. In order to allow oral disintegrating tablets to dissolve in the mouth, they are made of either very porous or soft molded matrices or compressed into tablets with very low compression force, which makes the tablets friable and/or brittle, which are difficult to handle, often requiring specialized peel-off blister packaging. 3-6 Along with the rapid market growth of ODT products, the technologies, too, have advanced considerably over the years. The newest generation of ODTs can produce more robust, versatile tablets that overcome some of the limitations of earlier ODTs. Companies such as Eurand can produce pleasant tasting tablets, overcoming the common problem of poor drug taste compromising the benefits of an ODT. In addition, some companies is developing controlled release ODTs, significantly broadening the applications of this dosage form. A key reason that companies choose an ODT over other delivery technologies is that it is a relatively easy and often less risky delivery option to develop. Since the route of administration remains the same, ODTs that are formulated as bioequivalent line extensions or generic versions of an existing oral dosage form have minimal clinical requirements to gain approval. 7Some of the common applications of ODTs are listed in table

   MEDICATION TYPE INDICATIONS

Fast acting Pain,   fever,   migraine,   diarrhoea,   heart burn, anxiety, insomnia Compliance-critical Parkinsons disease, Alzheimers disease, Psychosis, Schizophrenia, Hypertension, Cholesterol, Transplantation Paediatric Cough, cold, allergy, pain, fever

1.1 Requirements of ODTs: 8, 9, 10, 11

Ideal properties for ODTs:

The performance of ODTs depends on the manufacturing technology and the most necessary property of such a dosage form is the ability of rapidly

disintegrating and dispersing or  dissolving in the saliva,  thereby obviating the need for water intake. ODTs should depict some ideal characteristics to distinguish them from traditional conventional dosage forms. Important desirable characteristics of these dosage forms.

Convenient and easy to administer as does not require water for oral administration   for   swallowing   purpose,   but   it   should   dissolve   or disintegrate in themouth usually within few seconds.

  • Allow high drug loading.
  • Provide pleasant feeling in the mouth.
  • Be compatible with taste masking and other excipients.
  • Leave negligible or no residue in the mouth after oral administration.
  • Have sufficient strength to withstand the rigors of the manufacturing process and post-manufacturing handling.
  • Insensitive to environmental conditions such as humidity and temperature.
  • Adaptable and amenable to conventional processing and packaging equipments at nominal expense. Advantages of orally disintegrating tablets: 8, 9, 10, 11Improved compliance/added convenience Ease administration for patients who are mentally ill, disabled and uncooperative No water needed
  • Can be designed to leave minimal or no residue in mouth after administration and also to provide a pleasant mouth feel.
  • No chewing needed , Better taste obtained by taste masking Improved stability, low sensitivity to environmental conditionâSuitable for controlled/sustained release actives Allows high drug loading.
  • Ability to provide advantages of liquid medication in the form of solid preparation.
  • Adaptable and amenable to existing processing and packaging high speed machinery.
  • Cost   effective,   lower   production,   packaging   and   distribution   costs compared to current commercially available products.
  • The technology is versatile and suitable for the development of enhanced products for veterinary medicines, OTC, Rx medicines & line extensions.
  • The new proprietary method allows the incorporation of microencapsulated drugs for enhanced bioavailability, flexibility of dosing & immediate and/or controlled release.

For superior therapeutic benefit.

  • Mechanism of disintegrations by super disintegrants
  • The mechanism by which the tablets are broken into small pieces and then produce a homogeneous suspension is based on: Capillary action
  • By swelling
  • Air expansion
  • Due to disintegrating particle
  • Due to deformation
  • Due to release of gases
  • By enzymatic reaction.

Author(s): Mohammedi Iqra Mubeen

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