oral dissolving film by Atul batule.pptx

Presentation on research article of mouth dissolving film

1. Nav Maharastra Shikshan Mandal’s Abasaheb Kakade College of B. Pharmacy Bodhegaon,Tal – Shevgaon , Dist.- Ahmednagar Academic year 2023-2024 Made by- - Batule Atul Babasaheb - Shaikh Almas Nafis - Udage Tejas Shivaji Guided by- Dr.Hemant H Gangurde M.Pharm pharmaceutics (PHD) principal “Formulation & Evaluation of Mouth Dissolving Film’’

2. Introduction : NOVEL DRUG DELIVARY SYSTEM A novel drug delivery system  is a new approach that utilizes new technologies, innovative ideas, and methodologies to deliver the active molecules in safe yet effective concentration to produce desired pharmacological action. ADVANTAGES- Optimum therapeutic-drug concentration in the blood. Pre-determine release rate for an extended period of time Duration of short half life drugs may be increased. By targeting the site of action, side effect may be eliminated. frequent dosing and wastage of drug may be reduced or excluded. Better patient compliance may be ensured. DISADVANTAGES: Control release dosage form is more expensive than convectional dosage form. Reduced potential for the drug adjustment. In case of failure of dosage form the risk of dose dumping is present

3. Classification NDDS: Control release drug delivery system Sustain release drug delivery system Fast dissolving drug delivery system Delayed release drug delivery system Extended release drug delivery system Prolong release drug delivery system Targeted drug delivery system Microspheres Magnetic nanoparticles Nanoparticles Niosomes Monoclonal antibodies Resealed erythrocytes Liposomes Ocular drug delivery system liquids- solution, suspension semisolids-ointments, gels solids-ocular inserts, contact lens intraocular dosage form-injection transdermal drug delivery system rate-programmed system physical stimuli- activated system ` Implantable drug delivery system Passive implants Reservoir implants Monolithic implants Active implants Electromechanical device Osmotic pump mucosal drug delivery system Buccal Vaginal Nasal Ocular Rectal Oral Gastro-retentive drug delivery system Non-Effervescent system Effervescent system Low density system Swellable /expandable system Muco -adhesive systems High density system Fast dissolving drug delivery system Oral disintegrating tablets Mouth dissolving films

4. Fast dissolving drug delivery system Thin film strips Compressed tablet based system Lyophilized system Fast dissolving drug delivery system ,were first developed in the late 1970 as an alternative to convectional dosage form. Fast dissloving or quick dissolving dosage form have possessed great importance in the pharmaceutical field due to their unique properties and advantages. They udergo disintegration in the salivary fluids of the oral cavity within a minute, where they release the active pharmaceutical ingredient. The first developed fast-dissolving dosage form consisted in tablet form, and the rapid disintegrating properties were obtained through a special process or formulation modifications. ORAL DISINTEGRATING TABLETS FDA define orally disintegrating tablet in the ‘orange book’ as a “A solid dosage form which contain the medicinal substance or active ingredient which disintegrate rapidly within the matter of second when placed upon a tounge .” Product of ODT technology entered the market at 1980s. Ideal properties of ODTs Disintegrate without water Leave negligible or no residue in the mouth Compatible with excipients Insensitive to environment condition Must have sufficient strength Mouth feel should be pleasant Advantages of ODTs Good for patient with swallowing difficulties. Good for paediatric compliance Convenient to administer during travelling or working without need of water The pre-gastric drug absorption avoids the first pass metabolism.

5. advantages of oral dissolving film over the oral disintegrating tablets (ODT) ODTs are sometime difficult to carry ,store and handle. Many therapeutic possibilities in the following indications. ODTs are prepared by using the expensive lyophillisation process. A large no of drugs can be formulated as mouth dissolving films. Innovative products may increase the Pediatrics ( antitussived,expectorants,antiasthamatic ) Gediatrics (antiepileptic, expectorant) Gastrointestinal diseases Nausea (due to cyostalic therapy) Pain ( eg.migraine ) CNS ( eg.antiparkinsonism therapy)

6. MOUTH DISSOLVING FILMS Define :   The films are designed to dissolve upon contact with a wet surface, such as the tongue, within a few seconds, meaning the consumer can take the product without need for additional liquid.   The oral route is one of the most preferred routes of drug administration as it is more convenient, cost effective, and ease of administration lead to high level of patient compliance. The oral route is problematic because of the swallowing difficulty for pediatric and geriatric patients who have fear of choking. Patient convenience and compliance oriented research has resulted in bringing out safer and newer drug delivery systems  Patient convenience and compliance oriented research has resulted in bringing out safer and newer drug delivery systems. Recently, fast dissolving drug delivery systems have started gaining popularity and acceptance as one such example with increased consumer choice, for the reason of rapid disintegration or dissolution, self-administration even without water or chewing .

7. ADVANTAGES OF FAST DISSOLVING FILMS: Convenient dosing. No water needed. No risk of chocking. Taste masking. Enhanced stability. Improved patient compliance. The drug enters the systemic circulation with reduced hepatic first pass effect. Site specific and local action. Availability of large surface area that leads to rapid disintegration and dissolution within oral cavity. Dose accuracy in comparison to syrup. Disadvantage : The disadvantage of OS is that high dose cannot be incorporated into the strip. The dose should be between 1-30 mg. There remain a number of technical limitations with use of film strips; the thickness while casting the film. Glass Petri plates cannot be used for casting. The other technical challenge with these dosage forms is achieving dose uniformity. Packaging of films requires special equipements and it is difficult to pack.

8. Special features of fast dissolving films : Uno Film should be thin and elegant. Available in various size and shapes. Unobstructive . It should adhere to the oral cavity easily. Should processes fast disintegration without water. Rapid release. Ideal characteristics of a suitable drug candidate: The drug should have pleasant taste. The drug to be incorporated should have low dose up to 40 mg. The drug should have smaller and moderate molecular weight. The drug should have good stability and solubility in water as well as saliva. It should be partially unionized at the pH of oral cavity. It should have ability to permeate the oral mucosal tissue. ere to the oral cavity easily. Should processes fast disintegration without water. Rapid release.

9. Formulation -

10. Formulation table - Methods of preparation of mouth dissolving film solvent casting method Semisolid casting method hot melt extraction solid dispersion techenique rolling method Sr. No Ingredients (mg/ml) Batch No F1 F2 F3 F4 F5 F6 F7 F8 F9 1 Lamotrigine 25 25 25 25 25 25 25 25 25 2 HPMC E 15 150 150 150 175 175 175 225 225 225 3 Glycerine 0.5 0.3 0.7 0.5 0.3 0.7 0.5 0.3 0.7 4 Stevia 50 50 50 50 50 50 50 50 50 5 Croscarmellose sodium 20 20 20 20 20 20 20 20 20 6 Coloring agent q.s. q.s. q.s. q.s. q.s. q.s. q.s. q.s. q.s. 7 Water 5 5 5 5 5 5 5 5 5

11. Lamotrigine (API): Chemical Formula-C 9 H 7 Cl 2 N 5 Lamotrigine is an antiepileptic drug belonging in the phenyltriazine class. It is used in the treatment of both epilepsy and as a mood stabilizer in bipolar disorder. Lamotrigine is the first medication since lithium granted Food and Drug Administration (FDA) approval for the maintenance treatment of bipolar type I. It is approved for use in more than 30 countries. Selection of Polymer Two grades of HPMC E 5, HPMC E 15, sodium alginate, Instacoat universal SFC Film forming polymer , were tried for the formulation of film. Different concentration of all the polymer was used in alone. The polymer was dissolved into 5 ml of water and casted in film by casting of the solution in rectangular glass plate. The film was dried for 4 hrs at 30°C The best polymer was selected for the formulation on basis of the outcome of the evaluation like absence of whiteness and oiliness and good folding endurance with the fast disintegration. Glycerine Emolient ,humectant Stevia Sweetner

12. Cross carmilose cellulose - Superdisintegrants Coloring agent- Increasing the external appearance of formulation . Water- Diluent quantity sufficient Evaluation Parameter 1) Tensile Strength: We observed that increase in the concentration of polymer reflects the changes in all other variables. Specifically in the case of the polymer we observed that as the concentration of polymers increase, viscosity of the solvent system which was to be casted was increases. It affects thickness and brittleness of the film. A result showed that as the concentration of polymer increases, tensile strength of mouth dissolving film increases. A Result showed that as the concentration plasticizer increases tensile strength and % elongation of mouth dissolving film also increases

13. 2) Folding Endurance: Folding endurance gives an indication of brittleness of the film. A result showed that as the concentration of polymer and plasticizer increases, folding Endurance of mouth dissolving film increase. Batch No. In-vitro percentage drug release at 60 sec. F1 97 F2 86 F3 84 F4 99 F5 89 F6 86 F7 99 F8 89 F9 85 3) Weight variation measurement: A result showed that as the concentration of polymer increases weight of film also increases 4) Dispersion Study: In vitro disintegrating time for mouth dissolving film of lamotrigine was ranges from 20 to 40 sec. In vitro disintegrating time for mouth dissolving film of HPMC E 15 was ranges from 34.67 to 42.00 sec. All the formulations found to give minimum disintegration time as compared to other preparations.

14. CONCLUSION In conclusion, making mouth-dissolving film (MDF) for lamotrigine is a big step forward in making medicines easier to take. We've worked really hard to make this happen. Lamotrigine is super important for helping people with epilepsy and bipolar disorder. These films dissolve quickly in your mouth, so you don't need water to take them. They make it easier for people to stick to their treatment plan. As we keep working on this, we'll make sure the films work even better and follow all the rules 4) Dispersion Study: In vitro disintegrating time for mouth dissolving film of lamotrigine was ranges from 20 to 40 sec. In vitro disintegrating time for mouth dissolving film of HPMC E 15 was ranges from 34.67 to 42.00 sec. All the formulations found to give minimum disintegration time as compared to other preparations. 5) Surface pH: Surface pH of all mouth dissolving films prepared by using different polymers was found to be in the range of 6.5 to 7 pH, which was close to the neutral pH, which indicated that films may have less potential to irritate the sublingual mucosa, and hence, more acceptable by the patients. 6) ASSAY: -

15. FUTURE SCOPE – The future scope for mouth-dissolving film (MDF) formulations is vast and promising. Here are a few potential avenues: Expanded Drug Delivery : MDF technology can be applied to deliver a wide range of medications beyond lamotrigine . This includes other drugs for neurological disorders, cardiovascular conditions, allergies, and more. Customization and Personalization : There's potential to tailor MDF formulations to suit individual patient needs, such as adjusting dosages or incorporating multiple medications into a single film. Enhanced Stability and Shelf Life : Research can focus on improving the stability of MDFs, ensuring they remain effective for longer periods and are less sensitive to environmental factors like temperature and humidity. Advanced Drug Release Mechanisms : Further innovation in drug release kinetics can lead to more controlled and sustained release profiles, optimizing therapeutic outcomes and reducing side effects. Biodegradable and Eco-Friendly Materials : Development of MDFs using biodegradable materials can enhance sustainability and reduce environmental impact.

16. Integration with Digital Health Technologies : Integration with digital health platforms can enable monitoring of medication adherence and real-time feedback, improving patient engagement and outcomes. Targeted Drug Delivery : Research into targeted drug delivery systems can enable MDFs to deliver medications to specific sites in the body, reducing systemic side effects and improving efficacy. Combination Therapy : Exploration of MDFs for combination therapy, where multiple drugs are delivered simultaneously, can revolutionize treatment approaches for complex medical conditions. Overall, the future of MDF formulations holds immense potential for advancing drug delivery systems, improving patient outcomes, and transforming the landscape of healthcare delivery.

17. Reference - Kathapalia , H., & Gupte , A.(2013, Dec) An introduction to fast dissolving oral thin film drug delivery systems: a review. Retrieved from https://pubmed.ncbi.nlm.nih.gov/24274635/ Bhatt, S., Pathak , A., Grover, P., Bharadwaj , A., Bhatia, D., Tomar , R., & Kaurav , M. (2022). Different aspects of polymers – A review article. Volume 64, Part 3, Pages 1490-1495. Retrieved from https://www.sciencedirect.com/science/article/abs/pii/S2214785322031157?via%3Dihub Aggarwal , J., Singh, G., Saini , S., & Rana , A. C. (2011, June 12). Fast dissolving films: A novel approach to oral drug delivery. Retrieved from https://www.researchgate.net/publication/285975861_Fast_dissolving_films_A_novel_approach_to_oral_drug_delivery Reddy, T. U. K., Reddy, K. S. K., Manogna , K., & Thyagaraju , K. (2018, June). A detailed review on fast dissolving oral films. Retrieved from https://www.researchgate.net/publication/326580767_A_DETAILED_REVIEW_ON_FAST_DISSOLVING_ORAL_FILMS Nikam , S. D., Avhad , P. S., Chaudhari , A. A., Wagh , S. V., Rayjade , M. S., & Gosavi , P. Y. (2023, February). Review on: Recent advances in mouth dissolving film. International Journal of Pharmaceutical Chemistry and Analysis, 9(4), 163-168. Retrieved from https://www.researchgate.net/publication/368534675_Review_on_Recent_advances_in_mouth_dissolving_film Nagaraju , T., Gowthami , R., Rajashekar , M., Sandeep , S., Mallesham , M., Sathish , D., & Sharam Kumar, Y. (2013). Comprehensive review on oral disintegrating films. Journal of Advanced Pharmaceutical Technology & Research, 10(1), 96-108. [https://pubmed.ncbi.nlm.nih.gov/22920576/] Bhatt, S., Pathak , A., Grover, P., Bharadwaj , A., Bhatia, D., Tomar , R., & Kaurav , M. (2022). Different aspects of polymers – A review article. Volume 64, Part 3, Pages 1490-1495. Materials Today: Proceedings, https://doi.org/10.1016/j.matpr.2022.04.926 Mayuri , B., Sudheer Kumar, D., & Kishore, P. (2019). A Review on Epilepsy. Journal of Medical Science and Clinical Research, 07(03), 229. https://dx.doi.org/10.18535/jmscr/v7i3.229 Panigrahi , H., Jayanth , P. C., & Niranjan Babu , M. A review on epilepsy and its treatment. Retrieved from https://www.ijpcbs.com/articles/a-review-on-epilepsy-and-its-treatment.pdf Goldenberg, M. M. (2010). Overview of drugs used for epilepsy and seizures. Pharmacy and Therapeutics, 35(7), 392–415. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2912003/ Bala , R., Pawar , P., Khanna , S., & Arora , S. (2013). Orally dissolving strips: A new approach to oral drug delivery system. Journal of Pharmacy & Bioallied Sciences, 3(2), 67–76. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3757902/

18. Thank you everyone For your attention