Recommended
More Related Content
What's hot
What's hot (20)
Similar to Film dosage form
Similar to Film dosage form (20)
Recently uploaded
Recently uploaded (20)
Film dosage form
- 1. JSS COLLEGE OF PHARMACY, OOTY An ISO 9001:2015 Certified Institution, Approved by Pharmacy Council of India, Approved by AICTE, Accredited ‘A+' Grade by NAAC. FILM DOSAGE FORM Bhavesh Namdev, 1st M Pharm in Pharmaceutics, Dept of Pharmaceutics, JSS College of Pharmacy, Ooty
- 2. 1. INTRODUCTION 2. CLASSIFICATION 3. EQUIPMENTS 4. MANUFACTURING PROCESS 5. TECHNOLOGY 6. FORMULATION 7. PACKAGING 8. ADVANTAGES & LIMITATIONS 9. EVALUATION 10. APPLICATION 11. REGULATORY APPROVALS -INDIA 12. CONCLUSION 13. REFERENCE CONTENT
- 3. INTRODUCTION Ease of handling and convenient dosing also improve patient compliance. Fast-dissolving oral films are novel dosage forms which are particularly suitable for paediatric and geriatric use. Fast dissolving oral films (FDOFs) are the most advanced form of oral solid dosage form due to more flexibility and comfort. •It improve the efficacy of APIs by dissolving within minute in oral cavity after the contact with saliva without chewing and no need of water for administration . •The buccal cavity is an attractive route of administration for systemic drug delivery. Oral mucosa has a rich vascularization and offers higher permeability to many drugs.
- 4. Biopharmaceutical Classification of FDOFs Fast disintegrating oral film quickly disintegrate, facilitating the absorption of drug from the mouth, pharynx & esophagus through the oral mucosa . Distribution of drug depends on tissue permeability, perfusion rate, binding of drug to tissue permeability, drug interaction etc. It gives quick absorption and instant bioavailability of drugs due to high blood flow and permeability of oral mucosa is 4-1000 times greater than that of skin •OTFs also have an established shelf-life of 2-3years depending on the API but are extremely sensitive to environmental moisture video1
- 5. Properties Lyophilized system Compressed tablet based system Oral thin films Composition Solution or suspension of drug with excipients Active pharmaceutical ingredient with superdisintegrants Hydrophilic polymers with drug and other excipients Technology used Lyophilization Direct compression Solvent casting, hot melt extrusion Characteristics High porosity which allow rapid water or saliva penetration and disintegration Different levels of hardness and friability these result in varying disintegration and packaging needs Large surface area leads to rapid disintegration Classification of fast dissolving technologies Classification of fast dissolving technology For ease of description, fast dissolve technologies can be divided in to three broad groups. • Lyophilized systems. • Compressed tablet-based systems. • ORAL THIN FILM
- 6. EQUIPMENT Oral Film Coating Oral Film Roll Slitting Oral Film Packaging Vid`eo 2
- 8. A. In this method water soluble polymer and plasticizer are dissolved in the distilled water B. The solution is stirred up for 2 hrs in the magnetic stirrer and kept aside to remove all the air bubbles entrapped C. The active pharmaceutical ingredient and other agents are dissolved in small amount of solution and combine with bulk D. Remove entrapped air and resulting solution is casted as film and then dried which is then cut into pieces of the desired sizes Solvent casting
- 9. Hot Melt Extrusion A. In present method the mass is prepared first under the control of temperature and steering speed. B. Afterwards, the film is coated and dried in a drying tunnel, once again the temperature, air circulation and line speed are controlled. C. Then follows a slitting and in the last step the films are punched, pouched and sealed.
- 11. FORMULATION Active pharmaceutical ingredients Strip forming polymers Plasticizers Sweetening agents (Dextrose, Sucrose ,Fructose) Saliva stimulating agents (citric acid, malic acid 2-6%) Flavouring agents (depend on taste , age ) Coloring agents (titanium dioxide & FD&C app 1%) Stabilizing and thickening agents (natural gum 1%) ORAL STRIP FORMULATION COMPONENTS
- 12. PACKAGING Packaging A variety of packaging options are available for fast dissolving films. Single packaging is mandatory for films, which are pharmaceutical products. Every dose can be taken out individually ,Criteria that may be taken into consideration include the need for unit-dose packaging, barcode labeling, and the content in instructions for use, child-resistant seals, and senior-friendly packaging Polyester/suitable paper backed packaging Cassette packingAluminum sachet
- 13. Advantages & limitations DOSE ACCURACY PATENT LIFE EXTENSION A RAPID ONSET OF ACTION EASE OF ADMINISTRATION GOOD MOUTH FEEL PROPERTY ACCURACY IN THE ADMINISTERED REDUCED HEPATIC FIRST PASS EFFECT RAPIDLY DISSOLVED AND DISINTEGRATED STABILITY FOR LONGER DURATION OF TIME FLEXIBLE, COMPLIANT AND ARE NOT BRITTLE NO NEED OF WATER TO SWALLOW THE DOSAGE ALTERNATIVE OF CONVENTIONAL OTC DOSAGE FORMS SMALL DOSE REQUIREMENT CAN ONLY BE ADMINISTERED. UNSTABLE AT BUCCAL PH CANNOT BE ADMINISTERED TASTE MASKING- MOST DRUGS HAVE BITTER TASTE, AND NEED TASTE MASKING DRUGS WHICH IRRITATE THE MUCOSA CANNOT BE ADMINISTERED BY THIS ROUTE SPECIAL PACKAGING- OFDFS ARE FRAGILE AND MUST BE PROTECTED FROM WATER SO IT NEEDS SPECIAL PACKAGING
- 14. Mechanical properties Contact Angle Disintegration time Dissolution test Organoleptic evaluation Stability testing EVALUATION Electronic Tongue is very helpful for taste comprasion(organoleptic properities) studies especially for the generic companies.
- 15. Oral mucosal delivery via sublingual, buccal, and mucosal routes. APPLICATIONS Topical applications • The use of dissolvable films may be feasible in delivery of active agents such as analgesic or antimicrobial agents in the wound care and other applications. GASTRORENTENTIVE DELIVERY SYSTEM • Dissolvable films are being considered in the dosage form for which water soluble and poorly soluble molecules of various molecular weight are contained in film formate. Dissolution of film could be triggered by pH or enzyme secretion of gastrointestinal tract (GIT) and could potentially be used for treatment of gastrointestinal disorder. DIAGNOSTIC DEVICES • Dissolvable films may be loaded with sensitive reagent to allow controlled release when exposed to a biological fluid or to create isolation barriers for separating multiple reagents to enable a timed reaction within a diagnostic device.
- 16. REGULATORY APPROVALS - INDIA
- 17. COCLUSION • Fast dissolving oral films have several advantages over the conventional dosage forms. So they are of great importance during the emergency cases such as allergic reactions and asthmatic attacks whenever immediate onset of action is desired. • Being a consumer-friendly alternative, many of the pharmaceutical companies are switching their product franchise from ODTs to OSTs. • Oral fast dissolving films have emerged as revolutionary trend and extensive research activities involving various categories of drug are going on in this field. This technology covers vast category of patients specially geriatrics, pediatrics. Also it offers plenty of advantages over other dosage forms like enhanced bioavailability, and faster action
- 18. 1. Pallavi Patil., S. K. Shrivastava, Fast Dissolving Oral Films: An Innovative Drug Delivery System , International Journal of Science and Research (IJSR) 2. Arun Arya* , Amrish Chandra , Vijay Sharma and Kamla Pathak Fast Dissolving Oral Films: An Innovative Drug Delivery System and Dosage Form International Journal of ChemTech Research 3. R.P. Dixit, S.P. Puthli Oral strip technology: Overview and future potential Journal of Controlled Release 4. Alka Tomar , Kiran Sharma, Nitesh S Chauhan* , Ashu Mittal, Umakant Bajaj, Formulation and Evaluation of Fast Dissolving Oral Film of Dicyclomine as potential route of Buccal Delivery International Journal of Drug Development & Research. 5. Christina Graffner Regulatory aspects of drug dissolution from , european journal of pharmaceutical sciences 29 (2006) 288–293. 6. Suresh B, Halloran D, James L. Quick dissolving films: A novel approach to drug delivery. Drug.dev.tech. 2006;1-7. http://www.drugdeliverytech.com
Editor's Notes
- most important patient compliance cheaply manufactured because they don’t require sterile conditions The thickness of the film is about 0.381-1.27 cm. Size 1 – 20 cm sq depend on dose & drug loading But the oral films are more pliable and compliant and easily handled that’s why its change to from conventional dosage form to modified release dosage form and oral disintegrating tablets to the oral disintegrating films then rapidly disintegrates in a matter of seconds and dissolves to release medication for oromucosal absorption. Today, fast dissolving oral films are a well proven and worldwide accepted technology for the systemic delivery of API
- Before designing a new dosage form, the biopharmaceutical factor need to be considered , Factor like age , nature of the oral cavity, & blood flow to oral cavity should be considered . The pharmacodynamics performance of the dosage form is affected by different factor like age , sex & health of patient
- 1 taking a suspension or solution of drug with other structural excipients and, through the use of a mould or blister pack, forming tablet‑shaped units are then frozen and lyophilized in the pack or mould. Application - resulting units have a very high porosity, which allows rapid water or saliva penetration and very rapid disintegration. Dose handling capability for these systems differs depending on whether the active ingredients are soluble or insoluble 3 OTF -
- Solid Dispersion Extrusion: Solid dispersions are prepared by immiscible components and drug. Finally the solid dispersions are shaped in to films by means of dies. solvent Semisolid Casting: In this method solution of water soluble film forming polymer are mixed to solution of acid insoluble polymer to form homogenous viscous solution (e.g. cellulose acetate phthalate, cellulose acetate butyrate).After sonication it is coated on non-treated casting film. On drying The thickness of the film is about 0.381-1.27 cm. Rolling Method: In this method a solution or suspension containing drug is rolled on a carrier. The solvent is mainly water and mixture of water and alcohol. The film is dried on the rollers and gives desired shape and size
- Adv- Better uniformity of thickness and better clarity than extrusion. C Film has more flexibility and better physical properties. The preferred finished film thickness is typically 12-100 µm, Limitations - The polymer must be soluble in a volatile solvent or water
- Advantages: C Without use of any solvent or water. C Fewer processing steps. C Compressibility properties of the API may not be of importance. C Better alternative for poorly soluble drugs. C More uniform dispersion because of intense mixing and agitation. C Less energy compared with high shear methods Disadvantages: C Thermal degradation due to use of high temperature C Flow properties of the polymer are essential to processing C Limited number of available polymers
- The XGel™ film systems can be made to encapsulate any oral dosage form and can be soluble in either cold or hot water. XGel™ film is comprised of a range of different water soluble polymers, specifically optimized for the intended use Wafertab™ is a drug delivery system that incorporates pharmaceutical actives into an ingestible filmstrip. The system provides rapid dissolution and release of actives when the strip comes into contact with saliva in the mouth, additionally improved taste masking , potentially enhancing product stability . The Wafertab™ system lends itself to many possibilities for innovative product design, enabling multiple films with different actives to be bonded together. prepared in a variety of shapes and sizes and is an ideal method for delivery of medicine, Soluleaves technology is used to produce a range of oral delivery films that can incorporate active ingredients, colors, and flavors. cThis quality makes edible films an excellent delivery method for a large range of products requiring fast release in the mouth. Soluleaves™ films can also be designed to adhere to mucous membranes and to release the active ingredient slowly over 15 min. Foamburst It is a special variant of the Soluleaves™ technology where an inert gas is passed into the film during production. This results in a film with a honeycombed structure, which dissolves rapidly giving a novel mouth sensation
- The choice of flavors depends on age, taste and liking of the people like titanium dioxide or FD&C approved coloring agents which are incorporated up to 1% w/w Stabilizing and thickening agents To improve the viscosity and consistency of formulation, . Natural gum, like xanthan gum, carragenan, locust bean gum and cellulose derivative are loaded up to 5% w/w. agents Sweeteners are the essential constituent of pharmaceutical product for pediatric patients. Generally, two types of sweeteners are most commonly used which are natural sweeteners and artificial sweeteners. Sucrose is the major source of sweeteners; dextrose, fructose glucose and maltose are also source of sweeteners. The use of natural sugar is limited in diabetic patients Saliva stimulating agent To enhance the rate of production of saliva, saliva stimulating agents are added. Generally, acids such as citric acid, malic acid, lactic acid, ascorbic acid and tartaric acids are salivary stimulants. These agents are used in 2-6% w/w of weight of strip. Sweeteners also used as salivary stimulants. A variety of polymers are available for preparation of fast dissolving oral films. . The selection of film forming polymers, is one of the most important and critical parameter for the successful development of film formulation. The polymers can be used alone or in combination to provide desired film properties • Nontoxic and nonirritant. • Devoid of leachable impurities. • Should not retard disintegration time of film. • Tasteless. • Should have good wetting and spread ability property. • Should have sufficient peel, shear, and tensile strength. • Readily available. • Inexpensive. • Sufficient shelf life. • Should not aid in causing secondary infections in oral mucosa.
- 1.is a most commonly used peel-able container system with essentially zero transmission of both gas and moisture while providing a flexible primary packaging .The package is easier for the consumer to handle and to open easily. 2. Costly 3. is mainly used to carry multiple dosages of breath freshener/ herbal/dietary supplements in a set of oral films
- 1Accuracy in the administered dose is assured from every strip or film. 3Rapidly dissolved and disintegrated in the oral cavity because of large surface area which lowers dosage interval, improves onset of action, efficacy and safety profile of therapy. 4. Ease of administration to pediatric, geriatrics, bedridden patients and psychiatric patients who refuse to swallow tablets 5. Good mouth feel property helps to change the perception of medication as bitter pill particularly in pediatric patient. 6. Accuracy in the administered dose is assured from every strip or film. 7. The drug enters the systemic circulation with reduced hepatic first pass effect 8. Rapidly dissolved and disintegrated in the oral cavity because of large surface area which lowers dosage interval, improves onset of action, efficacy and safety profile of therapy. 9. Stability for longer duration of time, since the drug remains in solid dosage form till it is consumed. So, it combines advantage of solid dosage form in terms of stability and liquid dosage form in terms of bioavailability. 10. Oral films are more flexible, compliant and are not brittle as ODTS 11. No need of water to swallow the dosage form, which is highly convenient feature for patients who are traveling. 12.
- Thickness measured the thickness of strip by micrometer screw gauge at different stages to assure uniformity in the thickness. , Dryness test Tensile strength is a maximum stress applied to a point at which strip specimen break Contact Angle Goniometer determined the contact angle at room temperature. Put a drop of double distilled water on dry film surface. Image of water droplet recorded within 10sec of deposition by using digital camera. To determine angle, analyze digital picture. The contact angle was measured on both side of drop and averaged . Disintegration time For fast disintegrating oral films, the disintegrating time limit of 30 sec or less can be employed. But still no official guideline is present, this may be used as a qualitative guideline for quality control test. Generally, disintegration time for oral strip is 5-30sec Dissolution test Dissolution testing can be employed by using standard paddle or basket apparatus. Organoleptic evaluation Most of the people accepted products that possess features of sweetness and flavor. Special controlled human taste panels are used for product evaluation. Stability testing According to ICH guidelines Oral wafers have been stored under controlled conditions of 25°C/60% RH as well as 40°C/75% over a period of 12 months. During storage, oral wafers should be checked properly for their morphological properties, mass thickness, reduction of film thickness, tensile properties, water content and dissolution behavior.