Patent Perspective on Orodispersible Films

2020 ◽  
Vol 14 (2) ◽  
pp. 88-97 ◽  
Author(s):  
Suresh Gupta ◽  
Tegginamath Pramod Kumar ◽  
Devegowda Vishakante Gowda

: The traditional oral dosage forms (tablets, capsules, syrups, and elixirs) suffer from various disadvantages. They are pretty challenging to administer to patients with dysphagia, mucositis, and vomiting tendency. Therefore, gaining patient compliance using conventional dosage forms is highly cumbersome. One of the most transformative and innovative approaches to overcome such challenges is Orodispersible Films, a Novel Drug Delivery System. They are easy to consume, no need to chew or swallow and they do not even require water for consumption. Therefore, several drugs have been converted into orodispersible films to gain patient compliance. With the advent of these film formulations, new innovations are erupting and accordingly, companies in India are actively protecting them by filing ordinary patent applications in India and internationally under the Patent Cooperation Treaty. Patenting in India poses unique patentability challenges when compared with rest of the world. Nonetheless, meeting all the challenges and obtaining a valid patent not only help in recouping the cost involved in developing new drugs and its novel drug delivery systems but also helps in taking legal action against alleged infringers. This review article identifies key active Indian players in the domain of ODF based on their patent filings in India (and abroad) and also identifies the challenges they face to obtain a grant.

Author(s):  
Sagar T. Malsane ◽  
Smita S. Aher ◽  
R. B. Saudagar

Oral route is presently the gold standard in the pharmaceutical industry where it is regarded as the safest, most economical and most convenient method of drug delivery resulting in highest patient compliance. Over the past three decades, orally disintegrating tablets (FDTs) have gained considerable attention due to patient compliance. Usually, elderly people experience difficulty in swallowing the conventional dosage forms like tablets, capsules, solutions and suspensions because of tremors of extremities and dysphagia. In some cases such as motion sickness, sudden episodes of allergic attack or coughing, and an unavailability of water, swallowing conventional tablets may be difficult. One such problem can be solved in the novel drug delivery system by formulating “Fast dissolving tablets” (FDTs) which disintegrates or dissolves rapidly without water within few seconds in the mouth due to the action of superdisintegrant or maximizing pore structure in the formulation. The review describes the various formulation aspects, superdisintegrants employed and technologies developed for FDTs, along with various excipients, evaluation tests, marketed formulation and drugs used in this research area.


2016 ◽  
Vol 62 (1) ◽  
pp. 3-24 ◽  
Author(s):  
Aleksandar Aleksovski ◽  
Chris Vervaet ◽  
Rok Dreu

Hot melt extrusion and prilling are gaining importance as solvent free and continuous techniques in the production of solid oral dosage forms with added value, by incorporating active compound in a molten carrier which is further solidified to form solid dispersion. This article reviews these two techniques in terms of understanding process basics, equipment characteristics, required properties of processed materials and application of the processes for development of solid oral dosage forms. Studies revealed that both hot-melt extrusion and prilling are regarded as simple, robust and continuous methods for processing different types of materials and production of solid dosage forms based on solid matrices. However, understanding of their concepts and requirements together with careful material selection is crucial for stable material processing and obtaining stable products of high-quality. Hot-melt extrusion proved to be a suitable method for production of modified release dosage forms, taste masked dosage forms and dosage forms offering improved drug dissolution rate and solubility. Prilling till now has been successfully applied just in the production of multiple unit drug delivery systems for immediate and sustained drug delivery. Further studies on product development and process understanding are required for full implementation of prilling in the pharmaceutical field.


Author(s):  
Aditya Singh ◽  
Vaseem A. Ansari ◽  
Md Faheem Haider ◽  
Farogh Ahsan ◽  
Tariq Mahmood ◽  
...  

The concept of oral fast dissolving film is a new weapon of treatment to the remarkable pharmaceutical field over conventional formulation to enhance pharmacological activity and treat intrinsic and extrinsic factors that prevent nausea and vomiting to dissolve rapidly in the tongue. The oral fast-dissolving film is just like an umbrella that protects immediately from the rain because easy to administer and sudden onset of drug action is possible as the film is taken through the oral, buccal and sublingual route. The design and development of a promising technique with increased demand for the novel dosage forms to gain more patient compliance is an oral fast dissolving film. This product therapy is one of the best scientific innovative aha moment of targeted formulation for the delivery of active ingredients that requires no water for administration. This review article overview the novel opportunities in the oral dosage forms, application, formulation consideration method of preparation, marketed product and patented technologies of oral fast dissolving films.


2019 ◽  
Vol 9 (1) ◽  
pp. 303-317
Author(s):  
SANTOSH KUMAR RADA ◽  
Annu Kumari

Drug delivery by the oral route is the most prescribable and acceptable route in terms of patient’s compliance. Improvement of patient’s compliance has always a challenge towards the development of oral drug delivery system. In the market different types of oral dosage forms are available in which tablets, capsules, syrups, suspensions are preferred ones. Oral solid drug delivery faces drawback in case of swallowing especially with paediatrics and geriatric psychotic patients. Therefore scientists attracted towards fast mouth dissolving drug delivery systems to encounter existing problems with unique property of palatability and rapid disintegration. The concept of fast dissolving tablet came into existence in late 1970 and further improvements are still going on in connection with its preparation and methodology. Fast dissolving tablets have faster disintegration and dissolution rate and releases within 30 seconds as they come in contact with saliva. These systems also obviate the requirement of carry water during drug administration. This facilitate drug delivery to the patients of dysphasic, psychic, paediatrics, geriatric and bed-ridden, unconscious population. As fast dissolving tablets falls under desired expectation of safer, convenient and economical solid dosage forms, several techniques have been developed to improve disintegration quality in the recent past years. This article mainly focuses on formulation and evaluation technologies with recent advancement made so far in the field of fast dissolving tablets. Keywords: Fast disintegration; Dysphasia; Mouth dissolving; Self-medication.


Pharmaceutics ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 730
Author(s):  
Elisa Alessandrini ◽  
Francis Brako ◽  
Mariagiovanna Scarpa ◽  
Mariangela Lupo ◽  
Donato Bonifazi ◽  
...  

The paucity of evidence-based data on formulation characteristics preferred by the children is known to limit the design of tailored paediatric dosage forms. The European Paediatric Translational Research Infrastructure (EPTRI) commissioned a study to evaluate children’s dosage forms perceived preferences in some European countries and explore the feasibility of using the young persons advisory groups (YPAGs) to involve children in formulation research. An online, age-adapted survey was developed and translated into six languages. The survey link was disseminated across seven European countries: Albania, Italy, the Netherlands, and Dutch-speaking part of Belgium, Romania, Spain, and the United Kingdom. Respondents’ (n = 1172) perceived preferences for oral dosage forms primarily differed based on age, health status, and experience. Conventional dosage forms, i.e., liquid (35%), tablets (19%), and capsules (14%), were the most selected. Liquid was widely selected by children less than 12 years and by those healthy and taking medicines rarely. Monolithic solid forms were mostly chosen by adolescents and by children with a chronic disease taking medicines frequently. There was a clear lack of familiarity with more novel dosage forms (e.g., orodispersible films and granules). Noteworthy, granules were not appreciated, particularly by adolescents (52.8%). To rationalise the creation of paediatric formulations, it is important to involve children as active stakeholders and to apply tools assessing children’s perspectives on medicines to inform acceptable dosage form development from the start.


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