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MSK Final Project
MSK Final Project
MSK Final Project
Project report on
Bachelor of Pharmacy
Submitted by
Mr. MAYUR SURESH KHOPE
(B. Pharm IV Year)
Guided by
Prof. Snehal v. Pimpalshende
Assistant Professor
HI-TECH COLLEGE OF PHARMACY, CHANDRAPUR
CHANDRAPUR (MS.)
2O19-2020
2019-2020
CERTIFICATE
This is to certify that the Project work presented in this thesis entitled “A review on
2019-2020
CERTIFICATE
This is to certify that the Project work presented in this thesis entitled “A review on
The Project work submitted in partial fulfillment for course of Bachelor of Pharmacy
in the faculty of Science & Technology, Gondwana University, Gadchiroli.
2019-2020
DECLARATION
I am Mr. Mayur S. Khope hereby declare that the Project work presented in this
thesis entitled “A review on formulation and evaluation of antiseptic film
forming liquid for skin injury ” was carried out by me under the supervision of Prof.
Snehal v.Pimpalshende at Hi-Tech College of Pharmacy, Chandrapur.
2019-2020
Acknowledgement
It is a moment of great pleasure and immense satisfaction for me to express my respect and
reverence to Hi-Tech College of Pharmacy, Chandrapur for giving me the opportunity to
obtain the degree of Bachelor of Pharmacy.
I gratefully acknowledge the support of all teaching, non teaching and library staff of Hi-
Tech College of Pharmacy, Chandrapur for their valuable suggestions, support and advice
which I got time to time during my project work.
Words are not enough to express my deepest sense of thankfulness to Friends, for their
constant help and support. Friendship is all about trusts love & help each other and being
crazy together.
My family is the constant source of inspiration for me whose blessings are always with me
and which always helped me to move smoothly onto the road of success. My real sources of
inspiration are my Parents who come before God for me.
At last I want to extend my thanks to all those who directly or indirectly helped me for
completion of this project. I extend my deepest sense of gratitude to God for blessing.
INDEX
SRNO. CONTENTS Page no
1 Appendix 1
2 Introduction 3-9
3 Literature survey 10
12 Conclusion 21
13 References 22-25
APPENDIX
LIST OF TABLES
LIST OF FIGURES
gels and lotions are considered to reside for a relatively short period of time at
the targeted site. The localized treatment of body tissues, diseases and wounds
requires that the particular pharmaceutical component be maintained at the site of
treatment for an effective period of time.
Topical film forming formulations are intended for skin application or to
certain mucosal surfaces for local action or percutaneous penetration of
medicament or for their emollient or protective actions. These compositions
adhere to the body tissue, forming a thin transparent film and provide a localized
delivery of the pharmaceuticals to the body tissue.[2]
The aim of the drug administration via the skin can be either the local
therapy of dermatological diseases or the transdermal delivery of drugs to the
underlying tissues or the systemic circulation. Due to the considerable
advantages of the transdermal application route for some drugs different dosage
forms have been developed for the drug delivery through the skin: polymeric
patches and semisolids. Although the number of transdermally applied drugs is
limited the existing dosage forms are quite successfully marketed for various
indications. However, each of the dosage forms is associated with certain
drawbacks that can negatively influence the patient compliance or limit the usage
of the dosage form. Hence the search for alternatives to the conventional
transdermal dosage forms is reasonable to further improve the transdermal drug
application for the patient.[6]
Film forming solutions or gels has been used for example as tissue
glues for the sealing of operative wounds. A wide variety of other ingredients
such as fragrances, glycerol, petroleum jelly, dyes, preservatives, proteins and
stabilizing agents are commonly added to polymeric formulations and can be
used for the delivery of medication such as Antibiotics, Antiseptics, Antifungal,
Anti-acne agents, Corticosteroids, Moisturizing or Protective agents (such as
calamine) related to skin disorders and/or injury.[7]
The polymeric solution is applied to the skin as a liquid and forms an almost
invisible film in situ by solvent evaporation. Presently, film forming polymeric
solutions are well known from the field of surgery, wound care or skin
protection. In surgery, film forming preparations are for example used as tissue
glue for the thread-free closing of incisions or as disinfectants for the
preoperative skin preparation . Film forming polymeric solutions are also utilized
with or without antimicrobials active substances for the non-surgical care of
minor cuts and abrasions or in ostomy care for the protection of the skin
surrounding the ostomy wound against the aggressive bodily fluids. In contrast to
this, only very few authors have described the use of film forming systems for
the delivery of drugs to the skin. Misra et al. reported on a liquid film forming
solution for the biphasic delivery of testosterone but investigated only one
formulation containing a mixture of polyvinylpyrrolidone and polyvinyl alcohol
in isopropanol as film forming matrix without performing a polymer screening.
Also, Misra did not investigate the mechanical or cosmetical properties of the
formed film but focused mainly on the drug permeation from this system in vitro
as well as in film forming systemsdescribed in the literature are not applied as
liquids but as transdermal gels or cream.[10]
Similar to the works of Misra these groups investigated only one
individual formulation without testing a broader range of film formers and
focused also mainly on the drug delivery from the film forming system or the
clinical efficacy of the formulation . Due to the fact that film forming solutions
can provide many advantages over patches (higher dosing flexibility, higher
patient compliance due to improved cosmetical appearance) or semisolid
preparations (rub off resistance) the aim of this study was to test a wider range of
materials, to select suitable excipients and to characterize the properties of the
resulting formulations to provide a broader technological basis for the
development of this novel dosage for A first step formulation experiments were
performed with 14 polymers from different chemical classes. Basically the
compositions contained a film forming polymer dissolved in a volatile solvent.
Further excipients such as plasticizers or crosslinkers were added if necessary.
Mainly polymer content, type of plasticizer and plasticizer content were varied to
find the best composition for the desired purpose. Due to the fact that no suitable
evaluation method for these new application systems was available from the
literature a simple score system had to be developed in order to identify suitable
formulations for the intended application. The testing of the formulations was
performed in vivo as pre-experiments had shown that the special properties of the
skin (surface structure and movement) were very important for the differentiation
between the formulation variants. The evaluation system was based on five
criteria: viscosity, drying time, outward stickiness, cosmetical attractiveness and
integrity after a certain wearing time (18 h). These properties were considered
key features for the practical application of the novel dosage form especially
from the patients’ point of view: The viscosity of the film forming solution is
required to be low to enable an application of the dosage form as spray, which
would ensure an accurate, but at the same time flexible dosing and would be
most convenient for the patient. In order to avoid long waiting times for the
patient the novel dosage form is supposed to dry quickly on the skin. The formed
film is required to be non-sticky to avoid adhesion to the clothes of the patient.
Considering the fact that many patients complain about the high visibility of
transdermal patches which is considered cosmetically unattractive the formed
film is supposed to be almost invisible.[21]
In addition to this, the delivery system is required to show a certain permanence
on the skin in order to be able to provide a continuous drug supply over a
prolonged period of time. [28]
Following the polymer screening selected formulations with
polymers from different chemical groups were characterized concerning their
water vapor permeability and mechanical properties. Based on the observation
that the developed formulations had displayed similar mechanical properties, that
is flexibility and abrasion resistance, during the in vivo evaluation the
assumption was that they would also show similar mechanical properties in the in
vitro test method. If this was the case the in vitro method could serve as a useful
instrument in further polymer screening experiments for a more objective
evaluation of the developed formulations. [28]
WOUNDS
A wound can be described as a defect or a break in the skin, resulting
from physical or thermal damage or as a result of the presence of an underlying
medical or physiological condition. According to the Wound Healing Society, a
wound is the result of ‘disruption of normal anatomic structure and
function’. Based on the nature of the repair process, wounds can be classified as
acute or chronic wounds. Acute wounds are usually tissue injuries that heal
completely, with minimal scarring, within the expected time frame, usually 8–12
weeks.The primary causes of acute wounds include mechanical injuries due to
external factors such as abrasions and tears which are caused by frictional contact
between the skin and hard surfaces. Mechanical injuries also include penetrating
wounds caused by knives and gun shots and surgical wounds caused by surgical
incisions to for example remove tumours. Another category of acute wounds
include burns and chemical injuries, which arise from a variety of sources such
as radiation, electricity, corrosive chemicals and thermal sources. The
temperature of the source and the exposure time influence the degree of a thermal
burn. Burns will normally require specialist care because of the associated
trauma.[35]
Chronic wounds on the other hand arise from tissue injuries that
heal slowly, that is have not healed beyond 12 weeks and often reoccur. Such
wounds fail to heal due to repeated tissue insults or underlying physiological
conditions such as diabetes and malignancies, persistent infections, poor primary
treatment and other patient related factors. These result in a disruption of the
orderly sequence of events during the wound healing process (see later). Chronic
wounds include decubitis ulcers (bedsores or pressure sores) and leg ulcers
(venous, ischaemic or of traumatic origin). Wounds are also classified based on
the number of skin layers and area of skin affected. Injury that affects the
epidermal skin surface alone is referred to as a superficial wound, whilst injury
involving both the epidermis and the deeper dermal layers, including the blood
vessels, sweat glands and hair follicles is referred to as partial thickness wound.
Full thickness wounds occur when the underlying subcutaneous fat or deeper
tissues are damaged in addition to the epidermis and dermal layers. Ferreira et
al.have described wounds both acute and chronic that are difficult to heal as
‘complex wounds’ with unique characteristics.[38]
LITERATURE SURVEY
Until the mid 1962, the researches of wound dressing and healing
were somewhat neglected. It was supposed previously that the wound heal is
faster and more efficient, if it is kept dried and maintained uncovered. This
speculation was assume before establishing the ideal requirements for wound
healing materials. The pioneering work of Winter designed the first
generation of wound film or ‘‘dressings”, where he revealed that the epithelial
repair of wounded pig skin was at least twic compared to the air-exposed
wounds. Since this date, the studies and researches of wound dressing
development were further heightened; suggesting ideal wound dressings should
keep a wetted environment with high biocompatibility and prohibit the bacterial
infection for accelerating the tissue regeneration. In eighties, the wound dressings
were classified according to their wettability degree into dried and wet dressings.
The idea of the dried wound dressings was regarded the proper for wound
healing. Until the mid of 1970s, the woven cotton gauze or non-woven blends of
rayon with other fibers like polyester or cotton, were known as the most
frequently dressings I the market [15].
The traditional or dried dressings maintained the wound area dry, reduced the
wound size from view, allowed to absorb all wound exudates and fluids causing
leakage and provided further contamination. Thus, this behavio was classified as
a hostile for bacterial proliferation and also for viability of the mammalian cells
and tissue repair. According last investigations, Winter found that in case dried
dressings, a scab can covers the whole wound area which decreases the
epithelialization rate and inhibit the dressing rate. Therefore the gauze-cotton
dressings (dried dressings) which were earlier frequently utilized as wound
dressings became now not so useful because their own drawbacks, as follows
[16]: (i) Inability to protect the wound from microbial invasion, (ii) cause strong
pains for patients during the removal time, due to their big adhere on wound
surface, (iii) accumulated wound exudates at wound surface owing to their low
absorption rate, which facilitate the microbial attack, (iv low gases permeability,
(v) not suitable for chronic wounds, and (vi) keep the wound dried which
decreases the epithelialization rate and cell proliferation.[18]
Traditional dressings
Biological dressings
Artificial dressings
At present, PVA is one of the most frequently and the oldest synthetic
polymer have been employed as wound dressings, wound management, drug
delivery system , artificial organs, and contact lenses . However, PVA hydrogel
has inadequate elasticity, stiff membrane, and very incomplete hydrophilic
characteristics which restrict its use alone as wound dressing polymeric
membranes. Among the various hydrogels described in literatures, hydrogels
prepared using PVA blended with some natural polysaccharide and some other
synthetic ones are attractive and the most widespread route of membranes
synthesis, because of the abundance of such polymers, easily for chemical
,derivatization or modification, and usually good biocompatible .[20]
Table no.01:- List of currently available polymeric wound dressing materials in the
world markets.
Figure no.04 :-marketed antiseptic film forming liquids for skin injury.
METHOD
Spray method
Role of hydrogel membrane materials for enhancing and accelerating the wound
healing phases.
Assay
Identification
Colour
Antiseptic activity
1) Density
2) Viscosity
3) Iodine content
4) Spreadability
5) Antiseptic activity
1. Appearance
All prepared films were evaluated for their appearances i.e. if they are
transparent or opaque.
2. Thickness of film
The thickness of film was measured by vernier caliper. The thickness
uniformity was measured at five different sites of film and average of five
reading was taken with standard deviation.
3. Drying time
For the assessment of the drying time the formulation was applied to the
inner sides of the forearm after 2 minutes a glass slide was placed on the film
without pressure. If no remains of liquid were visible on the glass slide after
removal, the film was considered dry. If remains of liquid were visible on the
glass slide the experiment was repeated until the film was found to be completely
dry.
CONCLUSION
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