Mouth Dissolving Tablets

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conventional tablets cannot be swallowed with out water. However, water or any other fluid is needed, by the patients, in most of the cases to swallow the capsule or tablet. The difficulty in swallowing, more commonly termed as dysphagia, is apparent in patients of all age groups, especially the pediatrics and geriatrics. The result is a high incidence of non compliance and ineffective therapy. In case of patients who are mentally ill, uncooperative, nauseated patients and those with acute episodes of coughing or asthma the time of response should be very rapid which indicates that the drug should be absorbed into the systemic circulation as early as possible.
All the foresaid problems led to the development of an oral novel drug delivery system called ‘The Mouth Dissolving Tablets’ are defined as the solid dosage forms that dissolves or disintegrates quickly in the oral cavity, resulting in solution or suspension form without the need of water for the administration. They are also known as Rapid mouth dissolving tablet,Rapid melt, rapid dissolve, fast dissolve and quick disintegrating tablets. Thus, the mouth dissolving tablets have a significant impact on the overall patient compliance. Some Oral dissolving tablets can be given, to psychiatric patients, in the crushed form added in tea, there by decreasing the refusal rate by psychiatric patients for the administration of oral dosages.
The rapid dissolving tablets can be manufactured by three major technologies.

1) The conventional tablet processes with modifications
2) Freeze drying methods
3)Direct compression.
4)cotton candy process.
5)spray drying
6) sublimation.
7)mass extrusion
8)mouldind
9)nanonization
10)moulding and etc..

The present article is a comprehensive review which focuses on the significance of mouth dissolving dosage forms and the techniques available for their manufacturing.

Key words: Rapid melt, OD tablet technologies, Melt-in-mouth-tablets
Profile page link of the author: http://www.pharmainfo.net/poojachowdary
Profile page link of the guide: http://www.pharmainfo.net/ramamohan

Comments

Harsh bansal's picture

you are right that mouth dissolving is easy to inhale but normally its too costly then the same salt conventional dose why??? and by this preparation is it the effect on bio-availability of the drug?

harsh bansal

Pooja Chowdary's picture

Hello Bansal, Im sorry to say that it was quite difficult to understand your question. I did not understand the following highlighted terms in your question. "You are right that mouth dissolving is easy to INHALE but normally its too costly then the same SALT conventional dose why??? and by this preparation is it the effect on bio-availability of the drug?" I answered your question assuming INHALE to be INGEST; SALT to be SOLID. Its not too costly.. Most of the methods of manufacturing are cost effective. Even if they are costly, the advantages they offer compensate the cost significantly. The bioavailability is also high compared to the conventional tablets. Moreover the absorption and onset occur rapidly. In case of MDT's Disintegration occurs in less than 15 seconds and Onset of action occurs with in 3 minutes.. Don't these advantages compensate the cost? Yes, they do. Thanks and regards, Pooja

pooja

Arun Kumar Palle's picture

Very nice presentation. Can you please specify any other type of formulation of oral administration apart from mentioned in the presentation.
Pooja Chowdary's picture

Hello arun, I would be happy if your question is apecific. The other type of formulation of oral administration include buccal tablets, sublingual tablets, dispersible tablets, capsules, powders, pills, oral suspensions,oral emulsions etc.. Thanks and regards, Pooja.

pooja

Virag Shah's picture

Hello Madam, My doubt are 1. Is there any method for disintegration/dissolution study for obtaining the release of the drug from the dosage form 2. How can we find its absorption from different areas in GIT/ is there any model to study this. Regards, Virag Shah http://www.pharmainfo.net/viragshah
Pooja Chowdary's picture

Hello, There are methods available for the study of didintegration and dissolution of the drug from the dosage form. They can be tested for disintegration using conventional disintegration apparatus. Dissolution can also be be tested using the conventional disintegration tester but paddle method should be followed. Reference : http://rjpbcs.com/pdf/2010_1(4)/[65].pdf

pooja

Sandeep Reddy's picture

hi mam 1)what is the bioavailability of drug? 2) isthis kind of administration cause any inflmation in mouth ? then what will be the mechanism? 3)can you explain me the metabolism of the drug by this adminstration
Pooja Chowdary's picture

Hello Sandeep, Here are the answers for your questions. 1) The bioavailability is greater than the conventional tablets as the tablets disintegrate in the mouth itself. some drugs are absorbed from the mouth pharynx and esophagus as the saliva passes down into the stomach, in such cases bioavailability of drugs is increased. 2) This kind of administration may cause problem during mouth ulcers. But the tablet itself doesn't cause inflammation in mouth. In case of any adverse reaction the tablet can be expelled immediately. 3) The metabolism is a pharmacokinetic aspect. There is nothing that can be in the formulation that effects the metabolism. But the drug can be formulated as a prodrug. In the case of absorption of the drug though pharynx, esophagus etc the first pass effect is bypassed. Thanks and regards, Pooja

pooja

Sandeep Reddy's picture

thank u 1)how much time ittake to disintigrate in mouth?
Pooja Chowdary's picture

Hello, 15seconds to 3mins will be the disintegration time of MDTS in mouth. Thanks and regards: pooja

pooja

Madhu Mohan's picture

Hai What is the real advantage of Mouth dissolving tablets over the dispersable tablets? Is it possible to formulate all the drugs to mouth dissolving tablets ? what is the major limitations ?

Madhu Mohan Sri Venkateswara College of Pharmacy, Chittoor (A.P.) India

Pooja Chowdary's picture

Hello Mr. Madhu Mohan, Most of the advantages are same. The common advantages are 1. ease of swallowing. 2. Taste masking 3. Rapid onset of action. 4. Improved patient compliance. The real advantage is that the drug can be with out water. But for certain dispersible tablets water is required. The onset of action is more rapid in case of MDT's. In case the dispersible tablet is to be dispersed in a glass of water and then ingested then the patient has to wait for at least 3 minutes for the formation of dispersion but it is not the case with MDT's. The dispersible tablets also differ in the formulation. In case of MDT's super disintegrants are used which cause disintegration of the tablet with little quantity of saliva itself. Thanks and regards, Pooja

pooja

Sirisha Pingali's picture

hello pooja Nice presentation. Do these MDTs beat sublingual and other tablets in the near future?? In which case does these MDTs have significant use??

Sirisha Pingali

http://www.pharmainfo.net/sirisha

Viswanadha Institute of Pharmaceutical Sciences.

www.vnips.edu.in

Pooja Chowdary's picture

Hello Sirisha, Thank you for your appreciation. MDT's are not introduces recently. They are introduces about 10 to 12 years back. Both the sub lingual tablets and MDT's suffer same kind of absorption profile i.e., Absorption occurs through the linings of buccal cavity. Examples of drugs where MDT's have significant use include, 1> Clozapine( an antipsychotic agent )- Used to suppress both the positive and negative symptoms of schizophrenia. 2> Granisetron and ondansetron which are used in prevention of post operative nausea and vomitting show rapid onset of action. 3> Levocetrizine ( antihistaminic) MDT's to suppress allergic conditions arising due to histamine. 4> Salbutamol MDT's to treat acute conditions of asthma. The list includes many more drugs. These are only a few examples. Thanks And regards, Pooja.

pooja

Harsh bansal's picture

hello pooja, first of all i sorry to say u that your slide is very slow its waist the time never mind, my question is that can you tell me which tech is best for manufacturing out of 9 and why? and other question is you said their is no choking problem in case of pediatric too are you sour??? thankyou

harsh bansal

Pooja Chowdary's picture

Hello Bansal, I understand that it is tedious to wait for the slides to change but voice is tagged to the ppt. I hope you are aware of that. Your question on the best manufacturing technique should have been more specific. Every technique has its own pro's and con's. The selection of the technique depends on many factors viz., the nature of product, quantity and various other physical and chemical properties. As mentioned in the slides, Nanonisation may be a suitable technique for those drugs that do not undergo oxidation or hydrolysis but it cannot be used for drugs that undergo hydrolysis. Similarly, when a drug is incompatible with water soluble ingredients then tablet molding should not be the ideal process for manufacturing such tablets. Your second question is about chocking. Chocking occurs when a tablet is swallowed. But in the case of MDT's the tablets are not swallowed. Absorption occurs through the linings in the buccal cavity. Moreover, the MDT's have an advantage that any adverse or idiosyncratic reactions if observed the drug residual tablet in the mouth can be expelled. Conventional tablets do not offer such advantage. The same advantage is associated with other novel drug delivery systems like Transdermal drug delivery system where the patch can be removed in case of idiosyncracies. Thank you, Pooja.

pooja

Harsh bansal's picture

hello pooja yes you are right that its disintegrate in mouth and it is the main advantages of that types but you said that MDTS tablet takes 15seconds to 3mins for disintegration in mouth. i am going to my point again children can try it to swallow during this time and it may occur chocking what would u think that point???

harsh bansal

Sudha Thamarapalli's picture

hello pooja, Can you say the expected disintegration time for these type of tablets? Regards, Sudha.T

Regards,

Sudha.T

Pooja Chowdary's picture

Hi sudha, MDT's disintegrate rapidly. their disintegration time ranges from 15 seconds to 3 minutes. The rapid disintegration property can be attributed to the use of super disintegrants... Regards,

pooja

Arun Kumar Palle's picture

Can you please specify me about the action of saliva in degradation of drug?
Pooja Chowdary's picture

Hi, The saliva does not degrade the drug. Instead the tablet disintegrates in the saliva. As a well known fact, saliva is an aqueous fluid and most of the excipients used are water soluble. Furthermore, the super disintegrants are used which aid in disintegration with the little amount of saliva. The disintegration occurs by the swelling of disintegrating agents in a a way similar to that of the disintegration of conventional tablets. The only difference is that the MDT's disintegrate rapidly. I hope that the above explanation could clear your query convincingly. Regards,

pooja

Arun Kumar Palle's picture

Can you tell me about the effect on microrganisms in mouth when antibiotic formulations are used?
Pooja Chowdary's picture

As far as i could search i have found no antibiotic formulation in the form of MDT's that are used as antibiotics for the effecting the micro organisms in mouth. I will be happy if you can name some of those antibiotics. Systemic antibiotics like ofloxacin are currently available in the form of MDT's. Regards,

pooja

Sudha Thamarapalli's picture

hai, Can you specify the media used in performing the disintegration test? Because we cannot use water as we are not taking it with water. So, what it the invitro technique to determine disintegration? Regards, SUDHA.T

Regards,

Sudha.T

Pooja Chowdary's picture

As the conditions for the disintegration test should simulate the invivo conditions, the disintegration test can be performed using aqueous media which is buffered to pH 6.8 similar to the pH of saliva. Distilled water is most commonly used to perform disintegration test for MDT's. Regards,

pooja

Sudha Thamarapalli's picture

hai, What is the specified quantity of disintegration medium in case of these systems? You said that the drug should undergo buccal absorption with the mediation of saliva. and the disintegration time is from 15 s - 3 min. Is the patient supposed to keep the saliva in the buccal cavity for 3 min? Because it is most common that we will swallow the saliva. Regards, SUDHA.T

Regards,

Sudha.T

Pooja Chowdary's picture

most of tablets disintegrate in 15 seconds but swallowing saliva is easier than swallowing a tablet.. especially in case if geriatrics and pediatrics Regards, pooja http://www.pharmainfo.net/poojachowdary/biograph

pooja

Sandeep Reddy's picture

nice reply 1)can you explain me action of super disintegrants? 2)can you elborate the role of polymer in this system?
Pooja Chowdary's picture

Hi sandeep, The action of disintegrants has been clearly explained in slide no. 7 in the form of a conceptual diagram. Polymers are used in the Fast dissolving films for the purpose of film formation. Here water soluble polymers such as pollulan, CMC are used. Thanks,

pooja

Anil kumar appapurapu's picture

Abstract questions In case of patients who are mentally ill, uncooperative, nauseated patients and those with acute episodes of coughing or asthma the time of response should be very rapid which indicates that the drug should be absorbed into the systemic circulation as early as possible. All the foresaid problems led to the development of an oral novel drug delivery system called 'The Mouth Dissolving Tablets' are defined as the solid dosage forms that dissolves or disintegrates quickly in the oral cavity, resulting in solution or suspension form without the need of water for the administration. The difficulty in swallowing, more commonly termed as dysphagia, is apparent in patients of all age groups, especially the pediatrics and geriatrics. 1. MDT= Adv (conventional tablets + solution) explain 2. Saliva dissolves the MDT is it right? 3. Incase of cough (dry) and asthma the saliva secretion severely altered coming out in such cases how the MDT is useful? 4. How it is used in mouth ulcers Oral cavity? 5. which is better among liquids and MDT for pediatrics?

anilkumar

Pooja Chowdary's picture

Hello, here are the answers for your questions : 1. Well, The solution of the drug is formed when the drug is highly water soluble. In case the drug is less soluble or insoluble, a suspension of the drug is formed. As a well known fact the absorption from a solution or suspension is greater when compared to the absorption from a tablet mass. 2. The answer to your question is already mentioned in my previous post. The saliva initially causes the disintegration of MDT and later aids in the dissolution of the drug or at least converts it into a suspension or dispersion facilitating the easy absorption from the later absorption zone like esophagus,pharynx,etc... In case the API is highly water soluble then the rapid dissolution of the drug is also possible resulting in a solution of the drug making the absorption process less difficult. 3. In case of dry cough it is the nasal secretions that are affected not not the salivary secretions. Dry cough by definition is a cough which is not associated with sputum. Saliva and Sputum are different. hence in case of dry cough and asthma the effects, as mentioned by you, are less significant on salivary secretions. 4. In case of mouth ulcers these drugs may be less effective as the drug particles may irritate the ulcer. They can be used when ulcer protective agents are used in conjunct. 5. To choose between MDT and liquids (in case of pediatric patients), depends on the many reasons. The first reason is Patients will. The second reason is availability. The third reason is the cost. The fourth reason is palatability. As such all the formulations are not available in the form of MDT's as well as liquids. I hope my explanation could satisfactorily clear your quiery.

pooja

Anil kumar appapurapu's picture

well reply q1) is size of the MDT effects phase transition for absorption? if so which size is better? q2) is the disintegration process is dependent on saliva amount? if so what is the result in saliva reduced conditions? q3) pls clarify the 3rd point as in case of dry cough in some cases it is proven that saliva is excreted with the sputum

anilkumar

Pooja Chowdary's picture

The answers for these questions is already posted. For Reference:www.scipharm.at

pooja

Pooja Chowdary's picture

HI, The action of disintegrants has been clearly explained in slide no. 7 in the form of a conceptual diagram. Polymers are used in the Fast dissolving films for the purpose of film formation. Here water soluble polymers such as pollulan, CMC are used. Thanks, pooja

pooja

Sandeep Reddy's picture

thanks for answering all the best
Anil kumar appapurapu's picture

power point questions 1.slide.no.7. Which type of mechanism of disintegration will occur in mouth for MDT ? is it dependent on other ingredients? 2.slide.no.8. How can we increase the porous structure of the tablet matrix? if so what impact on release profile? 3.slide.no.19. In floss blending --- almost all MDT's contains water soluble ingredients then what is the use of surfactant? 4.slide.no.20. what is the recommended temperature and humidity to improve mechanical strength of MDT? 5.slide.no.25. Is it applicable to hydrophobic drugs? 6.slide.no.26. 1.How can the resin adsorbate will mask the bitter taste of drug used? 2.Conditions of MDT to release in solution form? 3.conditions of MDT to release in suspension form? 7.slide.no.28. In solutab technique you mentioned that coating with enteric polymer? if so where the drug is released in mouth or colon? if so wt about enteric coated tablet? 8.slide.no.30. is it Hardness or disintegration or both test(s) required officially? 9.slide.no.31. Why we choose sorenson's buffer of PH-6.8 for disintegration? thank you

anilkumar

Pooja Chowdary's picture

1)The action of disintegrants has been clearly explained in slide no. 7 in the form of a conceptual diagram. 2)The porous nature is explained in the presentation. porous matrix exhibits good mechanical strength.

pooja

Pooja Chowdary's picture

Hello Anil, please dont ask so many questions at a time because it may not create intrest for the viewers to go through your comments. please dont mind its just a suggestion.

pooja

Anil kumar appapurapu's picture

hello madam first of all i would like to say ALL THE BEST and now come to your comment if i ask questions individually i only get more marks you know that but i follow the actual definition for the questionnaire i.e ideal, quality and quantity,No repitition, reason based. i think it is better than what you followed like how the important of reducing dose frequency reduction of questions from same person should also reduced its not my opinion its all. there are certain reasons for asking the questions like this way includes 1. instead of asking so many questions in a different comment---i used in same comment- its good i think for the readers as they can view every thing at the same site 2. i think that questions asking means it should be ideal, quality and quantity, for that reason only a. Abstract questions b. PowerPoint questions c. theory based questions d. practical questions e. hypothetical questions i asked 3. in order to make an awareness towards the best competition in www.Pharmainfo.net i though it should be effective. as i believe that Pharmainfo net is the platform for us to show our desiring future goals 4. hard work never fails it is difficult to answer but you should try it to make it possible until the last minute thank you please don't mind its just a suggestion.

anilkumar

Pooja Chowdary's picture

Yes ofcourse you are right. but the thing is that. I too believe that Pharmainfo.net is the platform for us to show our desiring future goals. But as this is the exam season it is very difficult for us to answer 9-10 questions at a time. and we have to go through the commemts of other people also. hope you got what iam saying. Even though it is exam season i worked very hard to play an important role in the competition. And your comments are really very ideal and attractive. and i answered for your your questions now by keeping in mind that "HARD WORK NEVER FAILS" Thank you sir for your valuable suggestion.

pooja

Pooja Chowdary's picture

The answers for these questions is already posted. For Reference:www.scipharm.at

pooja

Pooja Chowdary's picture

its my pleasure.

pooja

Sudha Thamarapalli's picture

hai, Could you tell me few advantages of mouth dissolving tablets over mouth dissolving films? Regards, Sudha.T

Regards,

Sudha.T

Pooja Chowdary's picture

Hello sudha, Mouth dissolving films is a new frontier in MDDDS that provides a very convenient means of taking medications and supplements. In this technique, a non-aqueous solution is prepared containing water solluble film forming polymer drug and other taste masking ingredients, which is allowed to form a film after evaporation of solvent. In case of a bitter drug, resin adsorbate or coated micro particles of the drug can be incorporated into the film . This film, when placed in mouth, melts or dissolves rapidly, releasing the drug in solution or suspension form. Advantages of MDTS includes: 1)More rapid drug absorption from the pre-gastric area i.e. mouth, pharynx and oesophagus which may produce rapid onset of action. 2)Pregastric absorption can result in improved bioavailability, reduced dose and improved clinical performance by reducing side effects. 3)Good mouth feel property of MDDDS helps to change the basic view of medication as "better pill",particularly for pediatric patients due to improve taste of bitter drugs.

pooja

Anil kumar appapurapu's picture

1. give examples for MDT's by a) freez-drying, b) Molding, c) compaction technologies? 2. what are the various barriers of to attain systemic circulation by this delivery?

anilkumar

Pooja Chowdary's picture

Examples of MDTS which are prepared by following methods include: 1)Freeze drying-ex:Nimulid,Fizzic,setlers and etc... moulding:chloraseptic,Exedrin,HigoMD and etc..

pooja

Anil kumar appapurapu's picture

1. what is the responsible for viscous and adhesive properties of saliva ? 2. is saliva is hypotonic or hypertonic or isotonic when compare with extracellular fluids?

anilkumar

Pooja Chowdary's picture

1)Enzyme salivary amylase is responsible for viscous and adhesive properties of saliva. 2)saliva is hypotonic when compared to extracellular fluids.

pooja

Anil kumar appapurapu's picture

1. Can the drugs Nizatidine and Cisapride can be delivered by this mecahnism? 2. What is the purpose of freeze drying process at lower temp. in manufacturing MDT's? 3. What is the use of crystaline component used for the same

anilkumar

Pooja Chowdary's picture

1)Nizatidine and cisapride are not moputh dissolving tablets. 2)The low temperature in freeze drying provides a process producing tablets with enhanced structural integrety,while rapidly disintegrating in normal amounts of saliva. 3)use of crystalline components enhances the stability of the drug in mouth dissolving tablets.

pooja

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