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Crushed Tablet Formulations

Yasunori Miyazaki, Kozo Takayama, Tomonobu Uchino, Yoshiyuki Kagawa
Scientific approaches for dispensation are important for the quality and efficacy of drug treatments. Therefore, for the dispensation of powdered medicines, we have developed a powder blending method using a planetary centrifugal mixer (PCM) to replace the empirical manual method involving a mortar and pestle. The aim of this study was to optimize the formulation of pharmaceutical diluents for dispensing powdered medicines, using PCM. The diluents, composed of powdered lactose, crystalline lactose, and corn starch were assigned to a {3,2}-Simplex Lattice design...
2016: Chemical & Pharmaceutical Bulletin
Ahmad Ainurofiq, Syaiful Choiri
The purpose of this research was to develop an inclusion complex of meloxicam (MEL)/β-cyclodextrin (β-CD) incorporated into an orally disintegrating tablet (ODT), using statistical analysis to optimize the ODT formulation based on a quality by design (QbD) approach. MEL/β-CD complexation was performed by kneading, co-precipitation, and spray drying methods under different molar ratios. Fourier transform infrared spectroscopy, X-Ray diffraction, and thermal analysis were utilized to evaluate the complexes...
November 22, 2016: Pharmaceutical Development and Technology
Dimitrios Venetsanos, Sofia Sederholm Lawesson, Eva Swahn, Joakim Alfredsson
AIMS: To provide pharmacodynamic data of crushed and chewed ticagrelor tablets, in comparison with standard integral tablets. METHODS: Ninety nine patients with stable angina were randomly assigned, in a 3:1:1 fashion, to one of the following 180mg ticagrelor loading dose (LD) formulations: A) Integral B) Crushed or C) Chewed tablets. Platelet reactivity (PR) was assessed with VerifyNow before, 20 and 60min after LD. High residual platelet reactivity (HRPR) was defined as >208 P2Y12 reaction units (PRU)...
October 15, 2016: Thrombosis Research
Grace Li, Ofran Almossawi, Hasna Dulfeker, Vicky Jones, Felicity Taylor
AIM: To compare the palatability of oral non-soluble and oral soluble prednisolone tablets in paediatric patients admitted to the general paediatric wards in an acute London Trust. METHOD: As part of ongoing quality improvement initiatives, the Paediatric and Pharmacy departments compared tolerability of soluble versus non-soluble prednisolone in a group of 27 patients. Using a modified 5 point hedonic scale with 'smiley' faces we measured palatability and tolerance (swallowed versus refusal or vomiting) over two three week periods: the first period whilst soluble prednisolone was dispensed (n=17) and the second period after the switch to non-soluble prednisolone had been made (n=10)...
September 2016: Archives of Disease in Childhood
A C Walch, E Henin, J Berthiller, X Dode, B Abel, B Kassai, A Lajoinie
The purpose of this study was to interview paediatric nurses on administration issues using extemporaneous capsules and marketed capsules and tablets in children younger than 6 years old, based on most frequently administered drugs in six participating wards. The 59 responding nurses estimated respectively at 7.7±1.7 and 7.3±1.8years the age from which children would properly swallow extemporaneous capsules and marketed solids, with 33% and 37% of nurses considering that children under 6 would not get their prescribed treatment using these dosage forms...
September 25, 2016: International Journal of Pharmaceutics
Maria José Garcia-Fernandez, Nicolas Tabary, Feng Chai, Frédéric Cazaux, Nicolas Blanchemain, Marie-Pierre Flament, Bernard Martel
A β-cyclodextrin (β-CD) polymer obtained by crosslinking β-CD with citric acid in its water-insoluble (PCD-I) and soluble (PCD-S) forms was used as a multifunctional direct compression excipient for tablet designing. PCD-I powder was obtained after grinding the solid fraction through a 200μm grid. PCD-S powder was recovered after lyophilization or spray drying of the PCD-S aqueous solutions, eventually followed by a wet granulation step. Both PCD-I and PCD-S powders were characterized, separately and mixed in variable ratios, based on dynamic water vapor sorption, SEM, particle size distribution, tapped density, compressibility, and flowability...
September 25, 2016: International Journal of Pharmaceutics
David J Mastropietro, Srinath Muppalaneni, Hossein Omidian
OBJECTIVE: This study aimed to determine whether selected superabsorbent polymers (SAPs) could be used as a suitable alternative to thwart extraction, filtration, and syringeability attempts for abuse. Many abuse-deterrent formulations (ADFs) rely on high molecular weight polymers such as poly(ethylene oxide) to provide crush and extraction resistance. However, these polymers suffer from slow dissolution kinetics, and are susceptible to a variety of abuse conditions. METHODS: Several commercially available SAPs were evaluated for swelling behavior in extraction solvents, and tableting properties...
November 2016: Expert Opinion on Drug Delivery
Srinath Muppalaneni, David J Mastropietro, Hossein Omidian
OBJECTIVES: This study was conducted to evaluate suitable methods of testing crush-resistant tablets composed largely of thermoplastic polymers. The objectives were, i) to evaluate the effect of thermal processes on crush resistance, ii) to develop test method(s) to indicate whether a crush-resistant tablet is susceptible to tampering by insufflation based on generated particle sizes, and iii) to find an appropriate analytical tool for discriminatory studies. METHODS: We investigated the crush-resistance properties of poly(ethylene oxide) (PEO) tablets using three manual and four electrical devices...
October 2016: Expert Opinion on Drug Delivery
Samuel E F Orubu, Nicholas J Hobson, Abdul W Basit, Catherine Tuleu
OBJECTIVES: Dispersible tablets are proposed by the World Health Organization as the preferred paediatric formulation. It was hypothesised that tablets made from a powdered milk-base that disperse in water to form suspensions resembling milk might be a useful platform to improve acceptability in children. METHODS: Milk-based dispersible tablets containing various types of powdered milk and infant formulae were formulated. The influence of milk type and content on placebo tablet properties was investigated using a design-of-experiments approach...
June 28, 2016: Journal of Pharmacy and Pharmacology
Saurabh M Mishra, Bhagwan D Rohera
The objective of the present study was to design and develop a formulation for orally disintegrating tablets (ODTs) of carbamazepine using quality by design principles. The target product profile (TPP) and quality target product profile (QTPP) of ODTs were identified. Risk assessment was carried out by leveraging prior knowledge and experience to define the criticality of factors based on their impact by Ishikawa fishbone diagram and preliminary hazard analysis tool. Box-Behnken response surface methodology was used to study the effect of critical factors on various attributes of ODTs...
June 27, 2016: Pharmaceutical Development and Technology
Jessica L Hambly, Alison Haywood, Laetitia Hattingh, Raj G Nair
AIM: There is a lack of appropriate, commercially-available topical corticosteroid formulations for use in oral lichen planus (OLP) and oral lichenoid reaction. Current therapy includes crushing a dexamethasone tablet and mixing it with water for use as a mouth rinse. This formulation is unpleasant esthetically and to use in the mouth, as it is a bitter and gritty suspension, resulting in poor compliance. Thus, the present study was designed to formulate and pilot an effective, esthetically-pleasing formulation...
June 26, 2016: Journal of Investigative and Clinical Dentistry
Mona Darwish, Mary Bond, Yuju Ma, William Tracewell, Philmore Robertson, Lynn R Webster
OBJECTIVE: To compare the oral abuse potential of hydrocodone extended-release (ER) tablet developed with CIMA(®) Abuse-Deterrence Technology with that of hydrocodone immediate release (IR). DESIGN: Randomized, double-blind, placebo-controlled, crossover study. SETTING AND PATIENTS: One study site in the United States; adult nondependent, recreational opioid users. METHODS: After confirming their ability to tolerate and discriminate hydrocodone IR 45 mg from placebo, eligible participants were randomized to receive each of the following oral treatments once: finely crushed placebo, hydrocodone IR 45-mg powder, intact hydrocodone ER 45-mg tablet, and finely crushed hydrocodone ER 45-mg tablet...
June 21, 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
E Kersten, A Barry, S Klein
Oral drug administration to children poses specific pharmaceutical challenges that are often not seen to the same extent in adults, and whose occurrence may also be age dependent. When an age-appropriate dosage form is not available, manipulation of adult dosage forms (e.g., splitting and crushing of tablets or opening of capsules) has been reported as a means to facilitate administration to children. To enhance swallowability and/or mask an unpleasant taste of the dosage form to be administered, crushed/split tablets or the contents of capsules are often mixed with food or drinks or suspended in a vehicle prior to administration...
March 2016: Die Pharmazie
Soundos Saleh, Reiner Frey, Corina Becker, Sigrun Unger, Georg Wensing, Wolfgang Mück
Riociguat is approved for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Some patients have difficulty swallowing tablets; therefore, 2 randomized, nonblinded, crossover studies compared the relative bioavailability of riociguat oral suspensions and immediate-release (IR) tablet and of crushed-tablet preparations versus whole IR tablet. In study 1, 30 healthy subjects received 5 single riociguat doses: 0.3 and 2.4 mg (0.15 mg/mL suspensions), 0.15 mg (0.03 mg/mL), and 1...
March 2016: Pulmonary Circulation
Mark R Jones, Martin J Carney, Rachel J Kaye, Amit Prabhakar, Alan D Kaye
Prescription opioid abusers frequently tamper with opioid tablets in order to either accelerate the delivery of the euphoria-inducing agent or to alter the route of delivery, such that it may be delivered intranasally or intravenously. As one strategy to combat the opioid epidemic in the USA, drug manufacturers have begun to explore formulations which resist such tampering by abusers. Techniques to prevent tampering consist of physical barriers to crushing, chewing, and drug extraction, or aversive or antagonistic agents, incorporated within the formulation itself...
June 2016: Current Pain and Headache Reports
Kwabena Ofori-Kwakye, Kwadwo Amanor Mfoafo, Samuel Lugrie Kipo, Noble Kuntworbe, Mariam El Boakye-Gyasi
The study was aimed at developing extended release matrix tablets of poorly water-soluble diclofenac sodium and highly water-soluble metformin hydrochloride by direct compression using cashew gum, xanthan gum and hydroxypropylmethylcellulose (HPMC) as release retardants. The suitability of light grade cashew gum as a direct compression excipient was studied using the SeDeM Diagram Expert System. Thirteen tablet formulations of diclofenac sodium (∼100 mg) and metformin hydrochloride (∼200 mg) were prepared with varying amounts of cashew gum, xanthan gum and HPMC by direct compression...
January 2016: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
Yady J Manrique, Arron M Sparkes, Julie A Y Cichero, Jason R Stokes, Lisa M Nissen, Kathryn J Steadman
Acetaminophen (paracetamol) is available in a wide range of oral formulations designed to meet the needs of the population across the age-spectrum, but for people with impaired swallowing, i.e. dysphagia, both solid and liquid medications can be difficult to swallow without modification. The effect of a commercial polysaccharide thickener, designed to be added to fluids to promote safe swallowing by dysphagic patients, on rheology and acetaminophen dissolution was tested using crushed immediate-release tablets in water, effervescent tablets in water, elixir and suspension...
September 2016: Drug Development and Industrial Pharmacy
Min Xu, Paul Wan Sia Heng, Celine Valeria Liew
Compaction of multiple-unit pellet system (MUPS) tablets has been extensively studied in the past few decades but with marginal success. This study aims to investigate the formulation and process strategies for minimizing pellet coat damage caused by compaction and elucidate the mechanism of damage sustained during the preparation of MUPS tablets in a rotary tablet press. Blends containing ethylcellulose-coated pellets and cushioning agent (spray dried aggregates of micronized lactose and mannitol), were compacted into MUPS tablets in a rotary tablet press...
February 29, 2016: International Journal of Pharmaceutics
Khalid M El-Say, Tarek A Ahmed, Maged F Abdelbary, Bahaa E Ali, Bader M Aljaeid, Ahmed S Zidan
This study was aimed at developing risperidone oral disintegrating mini-tablets (OD-mini-tablets) as age-appropriate formulations and to assess their suitability for infants and pediatric use. An experimental Box-Behnken design was applied to assure high quality of the OD-mini-tablets and reduce product variability. The design was employed to understand the influence of the critical excipient combinations on the production of OD-mini-tablets and thus guarantee the feasibility of obtaining products with dosage form uniformity...
December 2015: Acta Pharmaceutica
Michael A Odeniyi, Nasir H Khan, Kok K Peh
The delayed release and mucoadhesive properties of Cedrela gum and hydroxypropylmethylcellulose blend in diclofenac sodium tablet formulations were evaluated. Tablets were prepared by direct compression and the crushing strength and detachment force were found to increase from 74.49 ± 1.22 to 147.25 ± 2.57 N and 0.302 ± 0.36 to 1.141 ± 0.05 N from low to high level of polymers, respectively. The release kinetics followed Korsmeyer-Peppas release and the n varied between 0.834 and 1.273, indicating that the release mechanism shifts from Fickian to super case I (anomalous release)...
May 2015: Acta Poloniae Pharmaceutica
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