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Sumario:
1. Análisis de formulaciones semisólidas en cuanto a:
a. Función de los componentes.
b. Tipo de base.
c. Tipo de semisólido.
d. Tecnología de preparación.
e. Control de la calidad.
f. Estabilidad.
2. Propuesta de nuevas formulaciones.
Bibliografía:
1. Essential of pharmaceutics. Remington. 2012.
2. Pharmaceutics. Dosage forms and design. FASTtrack. David Jones. 2008.
3. Modern Pharmaceutics. Basic principles and systems. Vol.1. Alexander Florence, Juergen
Siepmann. 2009.
4. Dermatological Preparations for the Tropics. A formulary of dermatological preparations
and background information on therapeutic choices, production and dispensing. Peter
Bakker and col. 2012.
5. Notas de clase.
Objetivos:
PÁGINA 1
A continuación se muestran dos formulaciones semisólidas del IFA antimicótico
ditranol, para su aplicación en el tratamiento de la psoriasis.
Formulación A Crema básica
Ditranol---------------------1g Cera lanette-------------------15g
Ácido ascórbico------------0.1g Parafina liquida---------------12.5g
Ácido salicílico--------------1g Petrolato-----------------------22.5g
Crema básica---------------98g Metilparabeno----------------0.15g
Agua purificada----csp----100g
PÁGINA 2
Psoriasis: se caracteriza por el incremento del grosor de la epidermis y su
escamación. Afecta áreas externas de la piel y cuero cabelludo. Puede tener
inflamación.
Tratamiento: emolientes-para hidratar y evitar piel seca que la caracteriza, evitar
las escamas.
Ditranol: es efectivo para la psoriasis crónica con placas. Se debe evitar contacto con
piel normal o sana por ser irritante.
PÁGINA 3
1. A continuación se muestran formulaciones farmacéuticas semisólidas:
Formulación A
Crema de ditranol:
Ditranol 1g
Ácido ascórbico 0.1 g
Ácido salicílico 1g
Crema básica 98 g
Crema básica:
Cera lanette SX 15 g (lanette wax=emulsifying wax)
Parafina líquida 12.5 g
Petrolato 22.5 g
Metilparabeno 0.15 g
Agua c.s.p. 100 g
Preparation:
Crema básica:
Melt together lanette wax, liquid paraffin and petrolatum over gentle heat and
mix.
Heat this mixture to approximately 70 °C.
Boil sufficient water for 1 minute. Dissolve the methylparaben in 50 ml of this
boiling water. Allow the rest of the boiled water to cool.
Allow the methylparaben solution to cool to approximately 70 °C.
Add this solution to the fat mixture (2.) at a temperature of approximately 70 °C
and mix.
Stir gently until cold.
Add enough recently boiled and cooled water to produce 100 g cream. Mix until
homogeneous.
Crema de dithranol
Mix the salicylic acid, ascorbic acid and dithranol.
Triturate this mixture carefully with approximately 2 g basic cream until
homogeneous.
Add the rest of the basic cream gradually and mix after each addition until
homogeneous.
Indicaciones:
Dithranol preparations are used for the treatment of psoriasis.
Dithranol cream is a water washable preparation and is therefore suitable for
hairy parts of the skin.
The cream is somewhat less effective, but better tolerated than the ointment.
Formulación B
PÁGINA 4
Ungüento de ditranol
Ditranol 1g
Ácido salicílico 0.5 g
Ungüento emulsionante 98.5 g
Ungüento emulsionante:
Cera lanette 30 g
Parafina líquida 25 g
Petrolato 45 g
Preparación:
Ungüento emulsionante:
Melt all ingredients together over gentle heat.
Stir gently until cold.
Ungüento de ditranol:
Mix the salicylic acid and the dithranol.
Triturate the mixture carefully with approximately 2 g emulsifying ointment and
mix until homogeneous.
Add the rest of the emulsifying ointment gradually and mix after each addition
until homogeneous.
PÁGINA 5
When sieves are available, sieve the zinc oxide, preferably through a 90 μm
sieve.
Melt the petrolatum over gentle heat.
Triturate the zinc oxide with the petrolatum.
Mix until no zinc oxide lumps are left and the preparation is homogeneous.
Preparation:
Mix the coal tar carefully with approximately 10 g zinc paste. Gentle heat may be
used.
Add the rest of the paste gradually and mix until homogeneous.
Therapy:
For external use only.
Zinc paste has good protective properties without being very occlusive. Due to its
high powder content,zinc paste may have a drying effect on the skin. It is used in
the healing process of clean ulcers, e.g., in leprosy.
As the zinc oxide particles in the paste reflect sunlight, zinc paste is an effective
sun blocking preparation.
Zinc paste is also used as a vehicle for tar and dithranol.
Clorhidrato de lidocaína……….5g
CMC A/V……………………….3g
Glicerina…………………………16g
Metilparabeno…………………..0.18g
Propilparabeno………………….0.02g
Agua purificada c.s.p…………..100mL
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