ISSN (Print): 1872-2113
ISSN (Online): 2212-4039
Volume 14, 4 Issues, 2020
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ISSN (Print): 1872-2113
ISSN (Online): 2212-4039
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Methods to Enhance Aqueous Drug Solubility
Guest Editor(s): Mohammad Tahir Ansari, Mohammad Tabish, Amit Kumar Nayak
Submit Abstract via Email
My experience of publishing in Bentham Science Publishers’ journal "Recent Patent in Drug Delivery and Formulation" has been quite productive and memorable.
I received excellent support and assistance during each and every stage of the publishing process, starting from the article submission to the final acceptance of my paper.
Dr. Bhavesh B. Patel
(Technical Services South Asia & SEA Health & Nutrition, Mumbai, India)
Has contributed: Review of Patents and Application of Spray Drying in Pharmaceutical, Food and Flavor Industry
3 Articles Ahead of Print are available electronically
Fast Dissolving/Disintegrating Dosage Forms (FDDFs) have received a widely acclaimed success in oral drug delivery with
their advantages of improving ease of oral administration, without-water administration, pre-gastric absorption and avoidance
of first pass metabolism. Commercial advantages are also due to product differentiation and patent term extension. Widespread
acceptability of FDDFs by patients and market success has led to the entry of Orally Disintegrating Tablets
(ODTs)/Orodispersible Tablets and Fast Dissolving Oral Films (FDOFs) into Pharmacopoeias across the globe. With the
progress in science and technologies, FDDFs have harnessed their potential in delivering drugs via some new routes of administration,
like vaginal and ocular.
Since their emergence in the 1990s in modern medicine, FDDFs have undergone a long development journey from immediate
release dosage forms to drug delivery via controlled, sustained and pulsatile approaches. Sublingual immunotherapy is a
tremendously successful approach in delivering allergens via oral route. With new manufacturing technologies like 3D printing,
it is now possible to design highly porous tablets of almost any shape. Macro and micro control features of 3D printing help in
optimizing not only quick disintegration of FDDFs but also facilitate incorporation of designed nanoparticles/microparticles to
achieve specialized drug release patterns. FDDFs have also gained access to personalized/precision medicine through new
technological innovations in 3D printing and rapid prototyping. 3D printing also enables loading of high amounts of drugs in
FDDF which could be a challenging task with other methods. Spritam (Aprecia Pharmaceuticals) is the first 3D printed FDDF
which received FDA approval in 2015 for the treatment of epilepsy.
FDOFs and lyophilized tablets have established themselves as an easy, safe and humane way of administering drugs and test
compounds orally in animals. Catalent, a US-based pharmaceutical company, is actively promoting its trademark technology
ZydisTM for animal health products via licensing and collaboration. ODTs have also found their novel applications in tablet
prototype screening and pharmacokinetic studies in animals. Further, preclinical testing in laboratory animals has been made
less cumbersome with the use of FDDF in delivering experimental drugs through oral route.
Ehtezazi et al. (Liverpool John Moores University, Liverpool, UK) discussed the inkjet, fused deposition modeling and
extrusion based 3D printing methods for preparing FDOFs . Process analytical technology, quality control tests, hardware
and suitable materials were suggested as critical challenges to be addressed for commercial manufacturing of 3D printed
FDOFs. Clinical trials reported in this paper for FDOFs highlights the wide acceptance of FDOFs not only by the
pharmaceutical industry but also by patients.
Almost any type of active ingredient, synthetic or natural, may be incorporated into FDDFs. Through a review on the latest
researches and marketed products, Singh et al. (Sardar Bhagwan Singh University, Dehradun, India) presented the expansion of
FDDFs in alternative systems of medicines and nutraceuticals . However, the dose, size limitations of dosage forms, compatibility,
stability and quantitative analysis play a critical role in the development and optimization of FDDFs containing
Dang et al. (International University, Vietnam) modified powder of Ocimum gratissimum seed via a swelling-milling process
for its use as a disintegrant in a model acetaminophen ODTs . Through this paper, modified powder of Ocimum gratissimum
seed is presented as a non-toxic, cost-effective, compatible and easy to manufacture disintegrant.
Kaur et al. (Rayat Bahra Institute of Pharmacy, Hoshiarpur, India) used a solvent evaporation method to modify the properties
of a binary mixture of crospovidone and microcrystalline cellulose for its use as a disintegrant . Fast disintegrating tablets
of febuxostat were prepared by a direct compression process and 32 factorial design was employed for optimizing formulation
for quick disintegration and drug release. Through this paper, co-processing of excipients is highlighted as a suitable
method to address the challenges of quick disintegration and the subsequent immediate drug release.
I am grateful to Prof. Stefano Giovagnoli, the Editor-in-Chief of Recent Patents on Drug Delivery and Formulation, for providing
this excellent opportunity to organize this thematic issue. I would like to thank all reviewers of this thematic issue for critically evaluating manuscripts and giving their valuable suggestions for improving the quality of papers. Thanks to all the
authors for the submission of quality manuscripts in this thematic issue.
The eyes have a vital role in our body. They permit us to visually perceive the surroundings and make correct movements
while performing physical acts. It would be a dark world without them. It is due to its delicate, sophisticated and intricate structure
that drug delivery to and through them has been the most challenging task for the pharmaceutical scientist. Eyes typically
exhibit high turnover of fluids (tears) and permit administration of only minute volume of formulations even for local effects. In
addition, cautions pertaining to impeding movement of eye lids, visual clarity, damage to corneal membrane etc. further restrict
the type of dosage forms as well as drugs qualifying for safe and effective delivery to the eyes. Systemic delivery through this
noninvasive route still remains a daunting and elusive task to the scientists.
Recently, there has been an upsurge in attempts aimed at tackling the obfuscating challenges and making drug delivery to
and across the eye more effective and safe. Formulations of nano pharmaceuticals, hydrogels exhibiting stimuli response as
well as less impedance to visual clarity, drug loaded contact lenses etc. are prudent attempts worth mentioning. This issue aims
at analyzing recent attempts made by researchers in the field of nano particles, advanced hydrogels, advanced bio inspired films
capable of sustained release etc. including patents filed in this niche area for various ocular diseases.
Several approaches like the use of liposomes, solid lipid nanoparticles, nano lipid carriers, nanoemulsions, nanosuspensions,
noisomes, polymeric micelles etc. have been investigated for enhanced drug delivery and pharmacodynamics . Advanced
hydrogels capable of responding to stimuli (temperature, pressure, pH, ions etc.) seem to have a distinct edge over the conventional
pre formed gels. They exhibit property of immediately accumulating the drug at the site of stimuli and decrease the burden
of loading the entire formulation at a non stimuli site . Nano particles containing anti-vascular endothelial growth factor
A have been investigated for successful treatment of age related macular degeneration. These particles have a distinct advantage
in terms of patient compliance over the conventional intravitreal injections .
The pharmaceutical scientists are constantly aiming at solving the problem of low ocular drug penetration due to low aqueous
drug solubility, poor retention, decreased permeation of the drug through the corneal epithelium, and loss of drug due to
high lacrimal fluid turnover. Interestingly, solubilizers frequently used for increasing the aqueous solubility of drugs in ocular
formulations are themselves irritating to corneal membrane and often produce disruption of corneal integrity. Hence, a nano
formulation free from solubilizers can be envisaged to offer unique advantage to the patient . Patents of nano formulations
for cataract, tear dysfunction syndrome, microbial diseases, high intraocular pressure etc. are a pointer to the gravity of the
situation because the ocular bioavailability of most drugs is often less than 5% .
Corneal damage due to repeated exposure to blue light emitting diode (exposure to TV, mobiles etc.) has become a common
problem in recent years. Free radical scavenging and adhesive properties are essential attributes of such protective gel formulations
. A major ocular concern, for a vast majority of diabetic patients is diabetic retinopathy. Success of drug therapy for
diabetic retinopathy requires sustained drug release from ocular formulations. A recent approach in this direction is the use of
bio-mimicking polymer – drug combination. The polymer mimics the active site of aldose reductase 2 enzyme and releases the
drug (ALR2 inhibitor) slowly over a long period of time, thereby resulting in prolonged control of intraocular pressure .
The compilation of manuscripts in this issue will be beneficial to the readers in gaining an insight into diverse strategies
being employed by the pharmaceutical scientists for overcoming the indomitable challenges for successful and effective ocular