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Orally Dispersible Tablets (ODT)

API & Drug Product Development >> Formulation Development >> Buccal / Orodispersible

We offer end to end pharmaceutical formulation development services of ODT tablets ranging from early phase development to clinical supplies for new chemical entities, generics and life cycle extension products.

Orally Disintegrating Tablets Development

API & Drug Product Development >> Formulation Development >> Buccal / Orodispersible, Buccal / Orodispersible

Quotient Sciences has almost 30 years of experience developing a breadth of formulations across a range of indications.

Sub-Lingual Tablets

API & Drug Product Development >> Formulation Development >> Buccal / Orodispersible

We offer end to end pharmaceutical formulation development services of sub lingual tablets ranging from early phase development to clinical supplies for new chemical entities, generics and life cycle extension products.

Buccal & Sublingual Tablets Development

API & Drug Product Development >> Formulation Development >> Buccal / Orodispersible

Preformulation/reformulation for solid, semi solid (only orals) and topical formulations dosage form, pre-clinical formulation, prototype development (lab scale) batches and tech transfer support.

Mouth Dissolving Tablet Formulation & Development

API & Drug Product Development >> Formulation Development >> Buccal / Orodispersible

SUSHEN Medicamentos (SUSHEN), is a global company of end-to-end pharmaceutical services with focus on drug delivery research and product development. SUSHEN’s expertise can bring a complex formulation project in to clinical and bioequivalence with superior quality, innovative solution.

Sub Lingual Tablet Formulation & Development

API & Drug Product Development >> Formulation Development >> Buccal / Orodispersible

SUSHEN Medicamentos (SUSHEN), is a global company of end-to-end pharmaceutical services with focus on drug delivery research and product development. SUSHEN’s expertise can bring a complex formulation project in to clinical and bioequivalence with superior quality, innovative solution.

Oro-Dispersible Tablet Development

API & Drug Product Development >> Formulation Development >> Buccal / Orodispersible

Formulation Development is the core activity at Zenvision Pharma and it includes Pre-formulation studies, formulation development, analytical method development & validation, stability studies, Dossier preparation & Technology Transfer.

Development of Orally Disintegrating Tablet

API & Drug Product Development >> Formulation Development >> Buccal / Orodispersible

GVK BIO adopts a comprehensive, time-bound strategy in developing stable products that are efficient in all quality aspects.

Buccal / Orodispersible Tablet ODTs are also called as orodispersible tablets, quick disintegrating tablets, mouth dissolving tablets, fast disintegrating tablets, fast dissolving tablets, rapid dissolving tablets, porous tablets, and rapidmelts. However, of all the above terms, for the development of orodispersible tablets, United States pharmacopoeia (USP) approved these dosage forms as ODTs. The European Pharmacopoeia has used the term orodispersible tablet for tablets that disperses readily within 3 minutes in the mouth before swallowing. United States Food and Drug Administration defined ODT as “A solid dosage form containing a medicinal substance or active ingredient which disintegrates rapidly usually within a matter of seconds when placed upon the tongue.” The disintegration time for ODTs generally ranges from several seconds to about a minute. Development of Orodispersible Drug Products There are several methods for the development of orodispersible tablets (ODTs) but the prepared products vary in their properties depending on the method of preparation. The properties in which they vary are mechanical strength of the tablets, swallowability, bioavailability, drug dissolution in saliva, stability, and to some extent taste. Various methods for the development of orally disintegrating tablet (ODTs) are molding, compaction, spray-drying, freeze-drying, and some special methods are melt granulation, phase transition, and sublimation. 1. Contract development of orally dissolving tablet CDMO formed by molding process are highly porous in structure, resulting in high rate of disintegration and dissolution. The process of ODT contract development CDMO includes moistening, dissolving, or dispersing the drugs with a solvent then molding the moist mixture into tablets by applying lower pressure in compression molding, but always lower than the conventional tablet compression. The powder mixture may be sieved prior to the contract development of buccal tablets of in order to increase the dissolution. Molded tablets have low mechanical strength, which results in erosion and breakage during handling. 2. Conventional methods for the contract development of orodispersible tablets (ODTs CDMO) such as dry granulation, wet granulation, and direct compression are also exist for the contract development of orodispersible tablets. Some important super disintegrants, which are used during development of buccal tablets, are crosspovidone, crosscarmellose sodium, sodium alginate, acrylic acid derivatives. Buccal tablets were developed by direct compression method using crosspovidone and sodium starch glycolate as super disintegrants. Even development of orally dissolving tablet (ODT CDMOs) of Carbamazepine were prepared by this method having microcrystalline cellulose and crosspovidone (2%-10%). In all the cases it has been found that preparation by compression method along with addition of super disintegrants in correct concentration obey all the properties during development of orodispersible tablets CDMO. 3. During the pross of development of Orodispersible tablets (ODT CDMO) process of hydrolyzed or unhydrolyzed gelatin as supporting agent for matrix, mannitol as bulk agent, and sodium starch glycolate or croscarmellose sodium as disintegrating agent. Sometimes in order to contract development of buccal tablets disintegration and dissolution, citric acid and sodium bicarbonate are used. Finally, the contract development of buccal tablets with spray-dried in a spray drier. Orodispersible tablet CDMO through this method are disintegrated in less than 20s. It is a new frontier in ODTs that provides a very convenient means of taking medications and supplements. In this technique, a non-aqueous solution is prepared containing water soluble film forming polymer (pullulan, carboxymethylcellulose, hydroxypropyl methylcellulose, hydroxyl ethylcellulose, hydroxyl propylcellulose, polyvinyl pyrrolidone, polyvinyl alcohol, or sodium alginate, etc.), drug and other taste masking ingredients, which is allowed to form a film after evaporation of solvent. In case of a bitter drug, resin adsorbate or coated microparticles of the drug can be incorporated into the film. This film, when placed in mouth, melts or dissolves rapidly, releasing the drug in solution or suspension form. The features of this system include paper thin films of size. Technology for Development of Orodispersible tablet (ODTs) Zydis Technology: Zydis formulation orodispersible tablet development is a unique freeze dried tablet in which drug is physically entrapped or dissolved within the matrix of fast dissolving carrier material. When zydis units are put into the mouth, the freeze-dried structure disintegrates instantaneously and does not require water to aid swallowing. The Saudis matrix is composed for the development of orally dissolving tablet CDMO of many materials designed to achieve a number of objectives. To impart strength and resilience during handling, polymers such as gelatin, dextran or alginates are incorporated. These form a glossy amorphous structure, which imparts strength. For the contract development of orally disintegrating tablet CDMO crystallinity, elegance and hardness, saccharides such as mannitol or sorbitol are incorporated. Water is used in the contract development process of buccal tablet to ensure production of porous units to achieve rapid disintegration while various gums are used to prevent sedimentation of dispersed drug particles in the manufacturing process. Collapse protectants such as glycine prevent the shrinkage of zydis units during freeze-drying process or long-term storage. Zydis products are packed in blister packs to protect the formulation from moisture in the environment. Durasolv Technology: Durasolv is the patented technology of CIMA labs. Orodispersible tablets developed (CDMO) by this technology consist of drug, filler and a lubricant. Orally disintegrating formulation developed by using conventional tableting equipment and have good rigidity. These can be packaged into conventional packaging system like blisters, strips. Durasolv is an appropriate technology for orally disintegrating tablet contract development requiring low amounts of active ingredients i.e. potent drugs. Dispersible tablet Technology: It offers formulation of ODT development CDMO with improved dissolution rate by incorporating 7-10 % of organic acids and disintegrating agents. Disintegrate include starch, modified starches, microcrystalline cellulose, alginic acid, cross-linked sodium carboxymethyl cellulose and cyclodextrins Orasolv Technology: OraSolv was Cima's first orodispersible / disintegrating dosage form. In this system active ODT development CDMO medicament is taste masked, contains disintegrating agent. The disintegration of ODT in the mouth is cause by the action of an effervescent agent, activated by saliva. The amount of effervescent agent during the development of buccal tablets general about 20-25% of the total weight of the tablet. The widely used effervescent disintegration pair Usually include an acid source (citric, tartaric, malic, fumeric, adipic and succinics) and acarbonate source (sodium bicarbonate, sodiumcarbonate, potassium bicarbonate and potassium carbonate, magnesium carbonate). In ODT development CDMO, The microspheres are loosely compressed to maintain the integrity of the coating. The major disadvantage of the OraSolv during the buccal tablet development formulations is its mechanical strength. For that reason, Cima developed a special handling and packaging system for OraSolv. Orally disintegrating tablet development (CDMO) requires a controlled environment at low relative humidity and protection of the final tablets with moisture impermeable blisters. Oraquick Technology: The Oraquick fast dissolving/ disintegrating tablets formulation utilizes a patented taste masking technology. This taste masking process does not utilize solvents of any kind, so leads to faster and more efficient production. During the contract development of orally disintegrating tablet CDMO processing low-heat is produced so this technique is suitable for heat sensitive drugs. KV Pharmaceuticals also claims that the matrix that surrounds and protects the drug powder in microencapsulated particle is more pliable. This technique gives tablets with good taste masking and quick dissolution in matter of seconds. Flashtab Technology: Flashtab technology (Ethypharm, France) for the contract development of orally dissolving tablets CDMO produces tablets by compression of granular excipients (Cousin et al., 1995). This technology uses almost the same excipients as do conventional compressed tablets. Contract development of orally disintegrating tablet Excipients used in this technology comprise two groups of components: disintegrating agents, such as carboxymethylcellulose or insoluble reticulated polyvinyl pyrrolidone; and swelling agents, such as carboxymethylcellulose, starch, modified starch, carboxymethylated starch, microcrystalline cellulose, and possibly directly compressible sugars. For the contract development of orally disintegrating tablet (ODTs) the mixture of excipients is prepared by either dry or wet granulation methods. The produced tablets are known to have satisfactory physical resistance and disintegrate in the mouth within 1 minute. Quick –Dis Technology: Lavipharm Laboratories Inc. (Lavipharm) has invented an ideal intraoral fast?dissolving drug delivery system, which satisfies the unmet needs of the market. The novel intraoral drug delivery system, trademarked Quick?Dis™, is Lavipharm’s proprietary patented technology and is a thin, flexible, and quick?dissolving film. The film is placed on the top or the floor of the tongue. contract development of mouth dissolving tablets CDMO. It is retained at the site of application and rapidly releases the active agent for local and/or systemic absorption. The Quick?Dis™ drug delivery system can be provided in various packaging configurations, ranging from unit?dose pouches to multiple?dose blister packages. The typical disintegration time during the contract development (CDMO) of orodispersible drug products, which is defined as the time at which the film begins to break when brought into contact with water, is only 5 to 10 seconds for the Quick?Dis™ film with a thickness of 2 mm. The dissolving time during the contract development (CDMO) of mouth dissolving tablets, which is may be defined as the time at which not less than 80% of the tested film is dissolved in aqueous media, is around 30 seconds for Quick Dis™ film with a thickness of 2 mm. The typical release profile of an active ingredient exhibited by a Quick?Dis™ drug delivery system is 50% released within 30 seconds and 95% within 1 minute. Frosta Technology: This technology patents by Akina. It uses the concept of formulating plastic granules and compressing at low pressure to develop strong tablets with high porosity. Plastic granules are composed of: Porous and plastic material, Water penetration enhancer and binder. The process of contract development (CDMO) of orodispersible formulation involves usually mixing the porous plastic material with water penetration enhancer and followed by granulating with binder material. The tablets obtained have better hardness and rapid disintegration time ranging from 15 to 30 s depending on size of tablet. Pharmaburst Technology: SPI Pharma, New Castle, patents this technology. It utilizes the co-processed excipients to develop ODTs, which dissolves within 30-40 s. This technology for contract development (CDMO) of mouth dissolving tablets involves dry blending of drug, flavour, and lubricant followed by compression into tablets. Tablets obtained have sufficient strength so they can be packed in blister packs and bottles. Evaluation of Orodispersible Tablets Hardness/crushing strength The hardness of the tablet is measured by using conventional hardness testers like Monsanto hardness tester. The limit is toward the lower range in order to help early disintegration in mouth. Friability It is a difficult job to maintain the percentage of friability during contract development (CDMO) of orodispersible tablets within the limit, since all the methods of CDMO orodispersible tablets have a tendency to increase the percentage of friability. In all aspect, the range is within limit of 0.1%-0.9%. Roche friabilator is used in conventional form in order to measure friability of the tablets. Wetting time Wetting time is the indication of the inner structure of the tablets and to the hydrophilicity of the excipients. Thus, wetting time of a dosage form is related with the contact angle. The lower the wetting time the quicker is the disintegration of the tablets. The wetting time during contract development (CDMO) of oral buccal tablets can be measured by using five circular tissue papers of 10 cm in diameter, which are placed in a petridish of 10 cm diameter. CDMOs for ODTs, Ten millilitres of water-soluble dye like eosin solution is added to the petridish. A tablet is carefully placed on the surface of the tissue paper. The time required for water to reach upper surface of the tablet is noted as the wetting time. Moisture-uptake studies It is an important study in the case of orodispersible tablets. This study is carried out in order to assess the stability of the tablets. Sub-Lingual Tablet development, Ten tablets were kept in the desiccators over calcium chloride at 37°C for 24 h. The tablets were then weighted and exposed to 75% relative humidity, at room temperature for 2 weeks. Required humidity was achieved by keeping saturated sodium chloride solution at the bottom of the desiccators for 3 days. CDMOs for orally dissolving tablet development, One tablet as control (without super disintegrant) was kept to assess the moisture uptake due to other excipients. Tablets are weighed and the percentage increase in weight is recorded. Disintegration test The in-vitro disintegration time was determined by disintegration test apparatus. The time for disintegration of orodispersible tablets is generally <1 min and actual disintegration time that patient can experience ranges from 5 to 30 s. ODTs CDMOs a tablet development is placed in each of the six tubes of the apparatus, and one disc is added to each tube. The standard procedure of performing disintegration test during Sub-Lingual Tablet development which has several limitations. ODT CDMOs It is expected that disintegration test for orodispersible tablets should mimic disintegration in mouth within salivary contents. Sunada et al. performed disintegration test by using modified United States Pharmacopoeia Apparatus II by taking 900 ml of medium maintaining 37°C with r/min 100. It was carried out by taking a cylindrical vessel. Orodispersible tablets were placed in basket sinker in the middle of the vessel with a distance of 6-8.5 cm. Even Narazaki et al. carried out the disintegration test with rotary-shaft method. The apparatus consisted of stainless steel wire gauze on which orodispersible tablets were placed and slightly immersed in medium. Dissolution test during contract development of Buccal delivery system. Here, the rotary shaft is used to provide rotation and mechanical stress. Dissolution test It is an important test as the drug-release profile can be obtained by performing this test. Both the USP dissolution test apparatus can be used. Dissolution of orodispersible tablets is very fast. Therefore, USP 2 Paddle-type apparatus at 50-100 r/min is used for dissolution testing. Swammy et al. carried out in vitro dissolution study of pheniramine maleate orodispersible tablets in type II apparatus with r/min 550 using 900 ml phosphate buffer of pH 6.8 at 37 ± 0.5°C as a dissolution medium. Dissolution test during contract development of Buccal delivery system USP type I basket apparatus have certain application in the case of orodispersible tablets, but tablet fragments or disintegrated tablet masses may become trapped on the inside top of the basket at the spindle. An erroneous-dissolution profile is obtained, where little or no effective stirring occurs. Thus, type II is more preferred due to reproducible-dissolution profile. Development of Buccal Tablets Buccal delivery of drugs provides an attractive alternative to the oral route of drug administration, particularly in overcoming deficiencies associated with the latter mode of dosing .Problems such as first pass metabolism and drug degradation in the GIT environment can be circumvented by administering the drug via buccal route. Contract development of Mucoadhesive drug delivery systems CDMO, Moreover, the oral cavity is easily accessible for self medication and be promptly terminated in case of toxicity by removing the dosage form from buccal cavity. It is also possible to administer drugs to patients who cannot be dosed orally via this route Successful buccal drug delivery using buccal adhesive system requires at least three of the following (a) A bioadhesive to retain the system in the oral cavity and maximize the intimacy of contact with mucosa during Contract development of Mucoadhesive drug delivery systems CDMO (b) A vehicle the release the drug at an appropriate rate under the conditions prevailing in the mouth and (c) Strategies for overcoming the low permeability of the oral mucosa. Buccal adhesive drug delivery stem promote the residence time and act as controlled release dosage forms. Novel buccal dosage forms: The novel type buccal dosage forms include buccal adhesive tablets, patches, films, semisolids (ointments and gels) and powders. A. Buccal mucoadhesive tablets: Buccal mucoadhesive tablets are dry dosage forms that have to be moistened prior to placing in contact with buccal mucosa for orally dissolving tablet ODTs development CDMO. Example: a double layer tablet, consisting of adhesive matrix layer of HPC and polyacrylic acid with an inner core of cocoa butter containing insulin and a penetration enhancer (sodium glycocholate). B. B. Patches and Films: Buccal patches consists of two laminates, with an aqueous solution of the adhesive polymer being cast onto an impermeable backing sheet, which is then cut into the required oval shape. A novel mucosal adhesive film called “Zilactin” - consisting of an alcoholic solution of HPC and three organic acids is used in orally dissolving tablet ODTs development CDMO. The film which is applied to the oral mucosal can be retained in place for at least 12 hrs even when it is challenged with fluids. C. Semisolid Preparations (Ointments and Gels): Bioadhesive gels or ointments have less patient acceptability than solid bioadhesive dosage forms, and most of the dosage forms during contract development (CDMO) of orodispersible tablets are used only for localized drug therapy within the oral cavity. One of the original oral mucoadhesive delivery systems -“orabase”- consists of finely ground pectin, gelatin and NaCMC dispersed in a poly (ethylene) and a mineral oil gel base, which can be maintained at its site of application for 15-150 mins.

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