scholarly journals Formulation and Quality Control of Orally Disintegrating Tablets (ODTs): Recent Advances and Perspectives

2021 ◽  
Vol 2021 ◽  
pp. 1-12
Author(s):  
Mohammadali Poursharifi Ghourichay ◽  
Seyed Hossein Kiaie ◽  
Ali Nokhodchi ◽  
Yousef Javadzadeh

Orally disintegrating tablets (ODTs) rapidly disintegrate or dissolve in the oral cavity without using water. Demand for ODTs has increased, and the field has overgrown in the pharmaceutical industry and academia. It is reported that ODTs have several advantages over other conventional tablets. Since some of them are absorbed from the mouth, pharynx, and esophagus as the saliva passes down into the stomach, in such cases, the bioavailability of the drug improves meaningfully. Furthermore, the immediate release property of ODTs makes them a popular oral dosage form in patients with swallowing challenges, children, and for cases with a need for rapid onset of action. The current review article explains the features of active ingredients and excipients used in the formulation of ODTs, discusses multiple ODT formulation and preparation techniques with their merits and demerits, and also, offers remedies for problems associated with ODTs. Moreover, quality control steps and required considerations are presented.

2021 ◽  
Vol 11 ◽  
Author(s):  
Deepak Sharma ◽  
Dinesh Kumar ◽  
Gurmeet Singh

Background: The delivery of therapeutic agents through the oral route remains the most favorable one as compared to other routes of drug administration. However, numerous disadvantages are encountered in conventional formulations such as low bioavailability, first-pass metabolism, gastric irritation, delayed onset of action, bitter taste, low retention time, frequent dosing, and non-localized drug targeting. All these problems encountered guide the various pharmaceutical industries to manufacture and develop a novel solid oral dosage form called lozenges. Lozenges are solid oral dosage forms of medicament, meant to be dissolved within the mouth or pharynx. It may consist of one or more than one medicinal agent contained in a sweetened and flavored base material. Objective: The present review is focused on various types, compositions, methodologies used to prepare the medicated lozenges and on different evaluation parameters that establish its safety and efficacy. It also put a light on different commercially available and reported medicated lozenges formulation. Method: The various review and research articles reported by different researchers were studied extensively by using the databases of Google Scholar, Pubmed, Scopus, Web of Science and various commercial websites that were also investigated for information regarding new products. Results: Lozenges provides various advantages in terms of patient compliance, rapid onset of action, prolonged retention time, enhancement of bioavailability, ease of manufacturing, localized drug targeting, sustained or controlled effect, and reduced dosing frequency. It has also the ability to incorporate the drugs belong to different therapeutic classes for treating various disorders related to oral cavities like gingivitis, dental plaque, mouth ulcers, throat pain, oral thrush, throat infection, periodontitis, and pharyngitis. However, its applicability is not only limited to localized action, but it has also been employed to deliver the drug systemically for the conditions such as cough, decongestion, runny nose, nausea, vomiting, allergy, low immunity, fever, body ache, the killing of worms and smoking cessation. Conclusion: It was concluded that it has been played an important role in the field of drug delivery and will continue to perform in the same way in the future as well.


2018 ◽  
Vol 8 (5) ◽  
pp. 241-247
Author(s):  
P Munija ◽  
G Srikanth

The rationale of this investigation is to design an immediate release oral dosage of Sumatriptan succinate by using microcrystalline cellulose as filler, camphor and menthol as subliming agents by direct compression method .The basic objective of this dissertation is to develop an orodispersible tablet of sumatriptan succinate used in anti-migraine with an aim of reduces the lag time and providing faster onset of action to relief the acute migraine effect immediately. Disintegrates and disperses in oral cavity within 30 seconds without the need of drinking water. Has pleasant mouth feel and there is no after taste or grittiness. Successfully discriminates the ability of three superdisintegrants to promote drug dissolution and proposes a model formulation for disintegrants performance testing and quality control purposes. The formulation F6 containing 8% of CCS and 10% of menthol showed disintegration time of 18seconds after drying. Menthol as subliming agent was found to be most effective of all other subliming agents as it had showed drastic effect on the drug release. Keywords: Sumatriptan succinate, sublimation, menthol, anti-migraine


2005 ◽  
Vol 1 (1) ◽  
pp. 36 ◽  
Author(s):  
Kyriaki Mystakidou, MD, PhD ◽  
Emmanuela Katsouda, MD ◽  
Efi Parpa, BA, MA ◽  
Marinos L. Tsiatas, MD, PhD ◽  
Lambros Vlahos, MD, PhD

Breakthrough pain is a transitory flare of pain occurring in most cancer patients against a background of otherwise controlled persistent pain. Treatment of breakthrough pain is a challenging phenomenon. Oral transmucosal fentanyl citrate (OTFC; brand name Actiqm, Cephalon Inc., West Chester, PA), a new opioid formulation with a unique delivery system, reflects the characteristics of breakthrough pain (rapid onset of action and short duration), making it an effective treatment for cancer patients who already receive opioids and experience flares of pain. This review article aims to present the role of oral transmucosal fentanyl citrate in the management of breakthrough pain in cancer patients. In particular, it is going to discuss the synthesis, clinical pharmacology, pharmacokinetic and pharmacodynamic properties, toxicity, and clinical efficacy of this novel agent.


2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
K. Senthilkumar ◽  
C. Vijaya

Etoricoxib is a potent, orally active, and highly selective COX-2 inhibitor that exhibits anti-inflammatory, analgesic, and antipyretic activities. The present research was undertaken to develop mouth dissolving films of etoricoxib to have rapid onset of action. Mouth dissolving film (MDF) is a better alternate to oral disintegrating tablets due to its novelty, ease of use, and the consequent patient compliance. Solubility enhancement and taste masking of etoricoxib were the two challenges solved by formulating drug-inclusion complex with beta-cyclodextrin (BCD). MDF prepared by solvent casting etoricoxib-BCD complex along with HPMC as film forming polymer was found to possess desirable physicomechanical properties. In vitro release of etoricoxib from MDF in simulated salivary fluid and 0.1 N HCl was more than 95% within 2 minutes. Taste masking and in vivo disintegration were in acceptable range as assessed by human volunteers. Etoricoxib MDF was further characterized by differential scanning calorimetry, powder X-ray diffraction, and scanning electron microscopy. The index of analgesia shown by etoricoxib MDF was comparable to that of immediate release tablets (100% activity within 40 minutes) in animal studies. Conclusively, the present study documents the development of a commercially viable formula for an MDF of etoricoxib with rapidity in pain management.


2012 ◽  
Vol 4 ◽  
pp. CMT.S7298 ◽  
Author(s):  
Claudia F. Clavijo ◽  
Rachael Rzasa Lynn ◽  
Uwe Christians ◽  
Jeffrey L. Galinkin

Breakthrough pain (BTP) is experienced by approximately 65% of children and adults with chronic pain. Undiagnosed or untreated BTP produces negative emotional, physical, and economic consequences. BTP episodes have a rapid onset and short duration. Short acting oral opioids are the cornerstone of BTP management. Oral medications available to treat BTP episodes like immediate-release morphine or oxycodone have a delayed onset of action so that there is a mismatch between the episode of BTP and the effect of the oral opioids. Novel fentanyl delivery systems for BTP offer pharmacokinetic properties that match the time profile of BTP. Among the transmucosal routes, intranasal fentanyl has gained popularity due to its high bioavailability, rapid onset of action, high potency, short duration, and ease of administration. Its efficacy and safety have been demonstrated in adults who are opioid tolerant. Although children with chronic cancer pain also experience BTP, there is paucity of data on the use of intranasal fentanyl for BTP in this age group.


2014 ◽  
Vol 10 (3) ◽  
pp. 207 ◽  
Author(s):  
Steven M. Simon, RPh, MD ◽  
Lee S. Schwartzberg, MD, FACP

Pain management in patients with cancer remains suboptimal. Breakthrough pain (BTP) is characterized by abrupt onset of severe pain in a background of otherwise stable managed pain and presents a substantial burden to patients, as it disrupts activities and quality of life. Rapid-onset opioids (ROOs), with an appropriate onset and duration of effect, provide new options for effective and well-tolerated management of BTP. All currently available ROOs are various formulations of transmucosal immediate-release fentanyl (TIRF) and, although they were originally developed and approved for use in children before painful procedures, are only approved for use in opioid-tolerant adult patients with cancer and BTP. The formulation options include oral lozenge, buccal tablet, buccal film, sublingual tablet, nasal spray, and a sublingual spray; each has practical considerations that vary with the product and route of administration. All have the common advantage of rapid entry into the systemic circulation via transmucosal absorption, avoiding hepatic and intestinal first-pass metabolism and allowing a rapid onset of action that rivals intravenous injections. Rapid onset and short duration of action allow good patient control of analgesia. The pharmacokinetic and analgesic properties of ROOs may allow reduction of the total opioid burden and associated adverse effects, while still providing effective pain relief. The shared TIRF risk evaluation and mitigation strategy program implemented in March 2012 has simplified enrollment and administration of these products to help mitigate the risks of abuse and misuse and to help ensure safe use in patients with cancer suffering from BTP.


2019 ◽  
Vol 9 (2) ◽  
pp. 461-468
Author(s):  
Rada Santosh Kumar ◽  
Annu Kumari

Mouth dissolving tablets have gained more popularity among solid oral dosage forms. They perform better than conventional tablets because of its ease of administration and patient’s compliance. It facilitates water less administration and rapid onset of action. It also helps in improving oral bioavailability. The fast disintegration followed by dissolution leads to quick therapeutic activity makes these tablets superior over available tablets and capsules. Disintegration is an important key step for any solid dosage forms to show its pharmacologic effect as any solid dosage forms should disperse into its fine particles from which it is prepared. In mouth dissolving tablets superdisintegrants are incorporated in right amount for quick disintegration with improved bioavailability. Based on the source various types of superdisintegrants are available. They are synthetic, semi-synthetic, natural, and co-processed.  In this review, main emphasis is given on different types of superdisintegrants used in mouth dissolving tablets, their mechanisms and applications. Keywords: Superdisintegrants, Mouth dissolving, Disintegration, Bioavailability


2020 ◽  
pp. 7-24
Author(s):  
Zhanna Kozlova ◽  
Ivan Krasnyuk ◽  
Yuliya Lebedeva ◽  
Ekaterina Odintsova

Oral mucosal drug delivery is an alternative method of systemic delivery with several advantages over both injectable and enteral methods. Drugs that are absorbed through the oral mucosa directly enter the systemic circulation, passing through the gastrointestinal tract and first-pass metabolism in the liver due to oral mucosa being highly vascularised. This results in rapid onset of action for some drugs because of a more comfortable and convenient way of delivery than the intravenous one. But not all drugs can be administered through the oral mucosa due to characteristics of the oral mucosa and physical and chemical properties of the drug.


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