Fast disintegrating oral dosage form

Details Fast disintegrating oral dosage form Fast disintegrating oral dosage form

1998-10-07

2000-07-04

Spear, James M.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

424435, 424439, 424441, 514770, 5147723, 514777, 514778, 514779, 514781, 514782, A61K 920

Patent

active

060835311

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to the field of pharmaceutical orally ingested solid dosage forms, which are designed to dissolve rapidly within the mouth. Currently two main technologies are used to obtain such type of dosage forms: (1) The active ingredient is mixed with water-soluble diluents and compressed on a tableting machine at low to medium compression force. This is the more conventional approach. (2) A suspension is prepared with the active ingredient and appropriate excipients. The suspension is dispensed into blister packs and freeze-dried.
Many people are unwilling and/or unable to swallow tablets, capsules or traditional solid dosage forms. One approach suitable for these persons is the use of effervescent tablets or granules. However, the use of effervescent tablets requires preparatory steps before administration of the drug and the presence of water and a suitable mixing container. In addition, the manufacture and stability of effervescent tablets is often problematic. Another possibility is the use of a chewing gum or chewing tablet containing a medicament capable of absorption through the buccal cavity. Substantial disadvantages inherent in such a delivery system are that many medicaments are not suited for buccal absorption and that many persons are not able to chew gums or tablets because of braces, dental work etc. Furthermore, gums are often difficult to prepare.
A more recent approach is the OraSolv.RTM. technology of the company Cima. Orasolv.RTM. is an oral dosage form, which involves incorporating microencapsulated drug ingredients into a tablet that dissolves in the mouth without the need for chewing or water. The Orasolv.RTM. tablets are obtained by compression and packed into special peel-off blister packs because their mechanical resistance is insufficient in normal blister packs. The OraSolv.RTM. tablets normally need 15 to 60 seconds to dissolve in the mouth, which is longer than ideally aspired to in modern fast melting oral dosage forms. The same disadvantage of dissolving not rapidly enough in the mouth is common with many other approaches to fast melting oral dosage forms.
A fast dissolving (normally in 3 to 5 seconds) oral drug delivery system named Zydis.RTM. is known from the company R.P. Scherer. The principle of this technology consists in preparing an aqueous suspension of the active ingredient and the excipients, which is dispensed into blister packs and the water removed by a freeze drying process. The final product is obtained by sealing the dried product in special peel-off blister packs--like Orasolv.RTM. due to lacking mechanical resistance in normal blister packs. A major disadvantage of this technology is the time-consuming and costly freeze-drying process. Furthermore, the effectiveness of a freeze-drying process always depends on the physico-chemical parameters of the active substances used. For certain active substances, especially such having a high solubility in water, it is therefore difficult or impossible to apply a freeze-drying process and consequently this technology. Finally, the development of units with high doses (up to 500 mg or even 1000 mg) of active ingredients and/or combinations of active ingredients is difficult or impossible, respectively with this technology.
The present invention addresses the needs mentioned above and the problems encountered with currently available technologies. The expensive freeze-drying process is avoided. The manufacture of the dosage form of the invention is simple and suitable for a broad range of active ingredients with different physico-chemical parameters, for high dose unit forms (up to e.g. 1000 mg, in particular 500 mg, of active substance) and also for combinations of active ingredients.
The present invention provides a solid pharmaceutical dosage form adapted for direct oral administration, i.e. for direct insertion into the mouth of a patient. This is particularly useful in administration of medicaments to individuals who cannot or will not chew, such as debilitated patients, patients who have diff

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