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A Complete Guide on Oral Dispersible films (ODF) 2022

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Pharmaceutical Oral Dispersible films (ODF) 

Films contain drug within an appropriate film forming material.Films are used via various routes such as oral, buccal,etc and can be used to cover and protect burns and wounds on the skin as well. Films can be made with one layer or many layers(multi-layer) in different shapes and dimensions. Films are suitable for drugs with small doses. Depending on the film forming material films can be made to release drugs instantly or in a sustained or controlled mode.

Films forming materials:

The properties of film forming materials affects the formation of the film and the quality efficacy of the final product.
Ideal film forming materials should be:
1. Non-toxic,non-irritating,odorless and tasteless
2. Chemically stable
3. Adequately flexible and robust
4. Preferred water soluble

Oral dispersible films:

Oral dispersible films are characterized as solid dosage forms that feature a thin polymeric strip that incorporates and delivers a pharmaceutical active component and dissolves quickly in the mouth without the need for water or chewing.

Advantages:

  1. Simple to administer
  2. This kind of medication administration method is appropriate for geriatric and pediatric patients who have trouble swallowing.
  3. This form of medication delivery method has a faster rate of disintegration and dissolution since the oral cavity has a big surface area.
  4. This can be taken at any time and anywhere without the need for water for administration.
  5. Then there are flexible films, which make storage and transportation a breeze.
  6. It can help with motion sickness, allergies, etc.
  7. Greater bioavailability and stability due to the fact that it stays in solid dose forms until it is taken.
  8. When compared to liquid dose forms, more precise dosing is available.
  9. The beginning of the action is more.
  10. Drug is safe and effective at lower doses

Disadvantages:

  1. High doses are challenging to incorporate.
  2. Only a small amount of the medicine can be included.
  3. Increasing drug penetration is more.
  4. The challenge of dosage uniformity.
  5. For medications that are poorly absorbed, procedures like iontophoresis cannot be used to increase bioavailability or penetration. since they might harm the oral mucosa Drug is safe and effective at lower doses.

General composition of films:

  1. Active ingredients
  2. Film forming materials
  3. Plasticizers
  4. Surfactants
  5. Colorant
  6. Film removing agent(liquid paraffin)
  7. Fillers

Preparation method:

Homogenization film forming method: this method is commonly used for films using PVA as the film forming material. The film forming material is first dissolved in water and filtered. The active ingredients are then dissolved in the polymer solution. If the active ingredients are water soluble, they should be micronized into fine powders before dispersing into the polymer solution. After the removal of air bubbles the drug containing polymer solution is painted onto a glass plate and dried. For large scale production, a painting machine can be used. The dried films are divided into small doses according to the dose of the active ingredients.

  1. Heat molding method:Drug powders are mixed with film-forming materials(eg:EVA beads) and compressed with heat into films. Drug powders can be added into pre-melted film-forming materials(eg:polylactide,polyglycolide) and cooled to form films after painting.

Films quality control:

The appearance of films should be smooth,uniform in thickness,colour and luster and without bubbles. Films should be stored hermetically to avoid decomposition and moistening the limit of microbes should conform to standards. Generally, weight variation limits should be ±15%,±10% and ±7.5% for film with doses of 0.02g or below,0.02-0.2g and above 0.2g,respectively.

Conclusion:

Oral disintegrating films should be swallowed once they have completely disintegrated in the oral cavity. Surprisingly, the patient’s medication should disintegrate and release in the GI tract after being eaten. Simply placing the ODF on the tongue or other oral mucosal tissue causes the film to get wet, quickly break down, and dissolve, allowing the drug to be released for immediate oral absorption. Its flexibility and enhanced API release rate within seconds make it the most advanced solid dosage form.
To achieve desired features such mechanical strength, drug loading capacity, drug release, and disintegration time, several polymers are employed in ODF either singly or in combination. The optimum formulation of ODF must disintegrate within a few seconds of making contact with the tongue, depending on the amount and kind of polymer chosen for the preparation. Physical strength, appearance, drug release profile, residual water content, dose consistency, organoleptic features, and stability are some of the quality attributes that define ODFs. As a result, the oral disintegrating films could be a cutting-edge, promising strategy for patient compliance with a quicker onset of effect.

Why choosing Senieer?

Senieer, a top supplier and manufacturer of pharmaceutical equipment worldwide, provides ONE STOP SOLUTION. For companies in the pharmaceutical, food, chemical, and cosmetics industries, Senieer is the best global partner. In China, Senieer has spent more than 34 years concentrating mostly on solid dosage forms. Integral process solutions that are trustworthy. We manufacture equipment in accordance with international standards including GMP, cGMP, and US FDA.
he one-stop solution services for complete projects, from advising to design, are improved by members of the Senieer technical team. We completely meet your demands and methods for resolving all of your problems.

 

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