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Binders in Pharmaceutical Granulation
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
HPMC is one of the most widely used excipients in general and is also frequently used as a tablet binder. It is also known as hydroxypropyl methylcellulose (HPMC) and is formed by reacting alkali cellulose with methyl chloride and propylene oxide to yield a mixed substitution cellulose ether. Various substitution ratios and MW grades are available. Primarily low-viscosity grades with substitution type “2910” (28−30% methoxy groups by weight and 4−12% hydroxypropyl groups) are used as tablet binders (Table 4.2). These grades are also very popular for film coating formulations. HPMC is listed in the USP/NF, Ph. Eur., JP, and FCC.
The administration of medicines to children
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
In recent pharmaceutical-technological research, various strategies have been developed to reduce the size of the classical solid dosage forms. Minitablets [14] and minicapsules [15] have been developed with sizes of less than 5 mm. As for paediatric use various dosages are required, drug formulations with multiple monolithic particles offer the best opportunities. Dose adaptation of multiple-unit systems is easy, comfortable and more exact than splitting tablets into pieces. Modification of drug release, e.g. by film coating, can be achieved for each unit. The units are offered in multiple-dose containers or a single dose is contained in a capsule or a tablet. Minitablets exhibit an excellent dose and shape uniformity. As they can pass the pylorus of the stomach in fastened and full state, they can minimise variations in bioavailability and accelerate the onset of drug action. Although minitabletting is more expensive than classical methods, one can assume that the best solid drug formulation for paediatric use at the present time is the minitablet. A single formulation for both children and adults is achieved when the appropriate amount of minitablets for an adult dose is filled into a capsule shell. When re-opening the capsule, paediatric doses with accurate content uniformity can be withdrawn. A special dosing instrument (Fig. 3b) can assist in safely dosing from multiple-dosage containers. The first products with minitablet technology, containing pancreatin with an enteric coating and valproic acid with a sustained-release coating, have already entered the market.
Bacognize
Published in Dilip Ghosh, Pulok K. Mukherjee, Natural Medicines, 2019
Bacognize Tablet: The standardised formulation manufactured at PHPL after careful observation of B. monnieri and its nature. The general dosage form was finalised from clinical trials conducted on ‘Bacognize’. The film coating technique as adapted to protect it from moisture and other parameters. Bacognize was further tested according to in-house parameters for standardisation.
Impact of nanosizing on the formation and characteristics of polymethacrylate films: micro- versus nano-suspensions
Published in Pharmaceutical Development and Technology, 2021
Sakib Saleem Yousaf, Abdullah Isreb, Iftikhar Khan, Enosh Mewsiga, Abdelbary Elhissi, Waqar Ahmed, Mohamed A. Alhnan
The film coating of solid dosage forms using organic solvents suffers from significant drawbacks, including: high cost (i.e. usage, recovery, and disposal), stricter regulations (e.g. emission limits), organic solvent residues (which are considered hazardous); in addition to health and environmental concerns (Lecomte et al. 2004b; Barkley et al. 2006; Carlin and Li 2008; Mehta 2008; Felton LA 2016). Consequently, a shift in the pharmaceutical industry to employ aqueous coating systems has been observed. Despite several advances in aqueous film coating technologies, the resultant film quality is substantially poorer than films produced through organic coating methods (Lecomte et al. 2004b); particularly in terms of uniformity/homogeneity (Siepmann and Siepmann 2008). Differences in uniformity can be attributed to the mechanism of film formation i.e. polymer-dispersed as particles in aqueous solvents, as opposed to dissolved in organic solvents. This leads to the formation of a rougher, partially coalesced and increasingly vulnerable film, susceptible to environmental changes; thus necessitating the implementation of post-thermal treatments (i.e. curing) to improve film properties (Siepmann et al. 2005; Carlin et al. 2016)
99mTc-labelled and pH-awakened microbeads entrapping surface-modified lipid nanoparticles for the augmented effect of oxaliplatin in the therapy of colorectal cancer
Published in Journal of Microencapsulation, 2020
Kuldeep Rajpoot, Sunil K. Jain
The extent of coating on MBs was determined by measuring the value of TWGs. Formulations EuB-SLN-OP and EuB-FA-SLN-OP exhibited nearly the same values of TWG with slight changes and were found to be 9.96 ± 0.73% and 10.03 ± 0.87%, respectively. Findings revealed that the release of drug from enteric-coated was dependent on coating thickness and showed an inverse effect on the release of the drug, which suggests that thickness of film coating was regulating the release mechanism of the drug. The drug leakage of EuB-FA-SLN-OP and EuB-SLN-OP formulations was investigated by employing a dialysis membrane. The relative drug release was suppressed in the case of EuB-FA-SLN-OP (Figure 3). The decreased drug release from EuB-FA-SLN-OP could be owing to the structural integrity of FA coupling, which may lead to a dual-barrier influence on the drug diffusion. Similar effects were also reported in a previous study (Vichai and Kirtikara 2006). The alginate control release of drugs from the MBs via the gel formation and subsequent diffusion of two components, i.e. sodium (Na+) and calcium (Ca2+) ions. The process of gel formation is irreversible and starts immediately as the Ca2+ ions, which are smaller than the polymer molecules diffuse in the alginate chain and bind with the vacant binding sites available in the polymer. As a result, a more densely crosslinked gel structure will be formed, which retards the drug release (Bansal et al.2016).
Optimization of the coating process of minitablets in two different lab-scale fluid bed systems
Published in Drug Development and Industrial Pharmacy, 2020
Maja Szczepanska, Piotr Paduszynski, Hanna Kotlowska, Malgorzata Sznitowska
Based on our experience with the coating process of MTs, the available literature [15] and risk management based on failure mode and effect analysis (FMEA) methodology, four process parameters were chosen for monitoring, as follows: inlet airflow rate (X1), product temperature (X2), coating mixture flow rate (X3), and spraying pressure (X4) (Table 1). The minimum and maximum values of the tested parameters were determined mainly based on our previous experimental work [16,17]. Temperature values were determined, however, based on theoretical assumptions. The Tg (glass transition temperature) of the polymer and the type and amount of a plasticizer were employed to determine the minimum film-forming temperature (MTF) for coating mixture, as indicated by the manufacturer of the coating mixture [14]. The minimum and maximum values of MFT range were used in the statistical analysis. As response values, to determine efficiency of the process and quality of the final product, film thickness (Z1), uniformity of film coating (Z2), and release of API after 130 min of dissolution (Z3) were examined. A statistical p-value < 0.05 was considered as significant.